Company · US
Teleflex Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (4 in 12 months)
303recalls (0 in 12 months)
219recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 50 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 43 |
| GCJ | Laparoscope, General & Plastic Surgery | 25 |
| FZP | Clip, Implantable | 18 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 17 |
| KOD | Catheter, Urological | 17 |
| CCW | Laryngoscope, Rigid | 16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 11 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 8 |
| FMI | Needle, Hypodermic, Single Lumen | 7 |
| LRW | Scissors, General, Surgical | 7 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 7 |
| KNW | Instrument, Biopsy | 6 |
| BZA | Connector, Airway (Extension) | 5 |
| BZD | Ventilator, Non-Continuous (Respirator) | 5 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 5 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 5 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 5 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 4 |
| BSR | Stylet, Tracheal Tube | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 2026 | K262531 | OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnCont Teleflex Medical, LLC | KNW |
| Sep 23, 2026 | K261418 | Liquick X-treme, Liquick X-treme Plus Teleflex Medical, IE | EZD |
| Jul 9, 2026 | K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture Teleflex Medical, LLC | NEW |
| May 6, 2026 | K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape Teleflex Medical, LLC | GAT |
| Jul 3, 2025 | K251054 | Hem-o-lok PurplePlus Large Polymer Ligating Clips Teleflex Medical | FZP |
| Apr 29, 2025 | K242495 | LMA Fastrach ETT SU Teleflex Medical | BTR |
| Mar 18, 2025 | K243553 | QuikClot Control+ Hemostatic Device Teleflex Medical | POD |
| Sep 18, 2024 | K241784 | Arrow® Nitinol Wire Teleflex Medical | DQX |
| Mar 22, 2024 | K233713 | Pilling Tracheostomy Tubes Teleflex Medical | BTO |
| Jan 12, 2024 | K232970 | Hem-o-lok® Ligating Clips Teleflex Medical | FZP |
| Aug 30, 2023 | K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) Teleflex Medical | BSO |
| Jul 25, 2023 | K231924 | EZ-IO Intraosseous Vascular Access System Teleflex Medical | FMI |
| Apr 28, 2023 | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) Teleflex Medical | FZP |
| Aug 29, 2022 | K222279 | Rusch Intermittent Urethral Catheters Teleflex Medical | EZC |
| Mar 22, 2021 | K202492 | EZ-IO Intraosseous Vascular Access System Teleflex Medical | FMI |
| Mar 30, 2020 | K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch Teleflex Medical | GAT |
| Mar 19, 2020 | K193530 | Deklene MAXX Teleflex Medical | GAW |
| Aug 21, 2019 | K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) Teleflex Medical | BSP |
| Jun 11, 2019 | K191268 | Force Fiber Suture Teleflex Medical Incorporated | GAT |
| Nov 2, 2018 | K180253 | Sheridan Endobronchial Tubes Teleflex Medical | CBI |
| Oct 10, 2018 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek sutur Teleflex Medical Incorporated | GAT |
| Apr 25, 2018 | K173321 | StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral Nerve Block Needle, Teleflex Medical | BSP |
| Apr 17, 2018 | K180588 | FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device Teleflex Medical | FMI |
| Jan 29, 2018 | K173596 | Rusch Intermittent Urethral Catheters Teleflex Medical | EZC |
| Oct 3, 2017 | K172016 | Force Fiber Fusion Suture Teleflex Medical Incorporated | GAT |
| Sep 7, 2016 | K161758 | Weck Auto Endo10 Automatic Endoscopic Clip Applier Teleflex Medical | FZP |
| Aug 19, 2016 | K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device Teleflex Medical | CCT |
| Dec 3, 2013 | K133202 | HEM-O-LOK LIGATING CLIP Teleflex Medical | FZP |
| Nov 27, 2013 | K132658 | HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS Teleflex Medical | FZP |
| Nov 6, 2013 | K130405 | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET Teleflex Medical | BWC |
| Sep 21, 2012 | K112958 | HUMID-VENT HEPA Teleflex Medical | CAH |
| Mar 10, 2010 | K100506 | FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK Teleflex Medical | GAT |
| Sep 10, 2008 | K082156 | ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 Teleflex Medical | GCJ |
| May 25, 2007 | K070561 | KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES Teleflex Medical | HTY |
| Apr 23, 2007 | K063758 | CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R Teleflex Medical | BTT |
| Feb 9, 2007 | K063778 | FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE Teleflex Medical | GAT |
| Nov 2, 2006 | K062914 | HEM-O-LOK LIGATION CLIP Teleflex Medical | FZP |
| Aug 18, 2006 | K061736 | COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA Teleflex Medical | BTT |
| May 17, 2006 | K060801 | DEKNA-LOK MODEL BP1000V2L Teleflex Medical | GAM |
| May 5, 2006 | K060519 | INTRODUCER ASSEMBLY WITH ROTATOR LOCK Teleflex Medical | DYB |
| Jan 7, 2005 | K043205 | RUSCH EASY TUBE Teleflex Medical | BTR |
| Dec 16, 2004 | K043258 | MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 Teleflex Medical | KNT |
| Sep 28, 2004 | K042141 | POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE Teleflex Medical | GAM |
| Mar 15, 2004 | K040472 | FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE Teleflex Medical | GAT |
| Jan 15, 2004 | K033654 | FORCE FIBER Teleflex Medical | GAT |
| Nov 17, 2003 | K033115 | ORTHODEK Teleflex Medical | GAM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2022 | TELEFLEX MEDICAL INC (1) Teleflex Flex tube, Product #20011, sterile;
(2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile;
(3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; Open, Classified |
BZO | None listed |
| Apr 11, 2022 | TELEFLEX MEDICAL INC (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile;
(2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile;
(3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, Open, Classified |
BYD | None listed |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit)
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotato Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative)
Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunctio Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS
The Arrow-Trerotola Percutaneous Thrombolytic Devic Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS
The Arrow-Trerotola Percutaneous Thrombolytic Dev Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C,
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Terminated |
QEW | K011056 |
| Feb 18, 2021 | TELEFLEX MEDICAL INC RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation. Terminated |
CCW | None listed |
| Feb 12, 2021 | TELEFLEX MEDICAL INC PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thora Terminated |
GBX | None listed |
| Aug 7, 2020 | TELEFLEX MEDICAL INC Pleur-evac Thoracic Catheters
Catalog No: DTRC-20S
The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is in Terminated |
GBX | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004551035
GTIN:7290102156443 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tr Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004551004
GTIN: 24026704553796 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004551003
GTIN: 14026704663122 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004551002
GTIN: 14026704663115 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004550004
GTIN: 14026704663085 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 0004550003
GTIN: 14026704663078 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004550002
GTIN: 14026704663061 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jun 30, 2020 | TELEFLEX MEDICAL INC Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid Terminated |
KDQ | None listed |
| Jun 30, 2020 | TELEFLEX MEDICAL INC Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from r Terminated |
KDQ | None listed |
| May 29, 2020 | TELEFLEX MEDICAL INC RUSCH LASERTUBE (Rubber), RES 102004, Sizes:
a) I.D. mm 4,0, Product Code 102004-000040
b) I.D. mm 5,0, Product Code 102004-000050
c) I.D. mm 6,0, Product Code 102004-000060
d) I.D. mm 7,0, Product Co Terminated |
BTR | K935842 |
| Feb 7, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System Terminated |
CCW | None listed |
| Feb 7, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System Terminated |
CCW | None listed |
| Feb 7, 2020 | TELEFLEX MEDICAL INC HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit Terminated |
BTT | K131912 |
| Feb 7, 2020 | TELEFLEX MEDICAL INC HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit Terminated |
BTT | K131912 |
| Feb 7, 2020 | TELEFLEX MEDICAL INC HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit Terminated |
BTT | K162242 |
| Feb 7, 2020 | TELEFLEX MEDICAL INC HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit Terminated |
BTT | K162242 |
| Jan 27, 2020 | TELEFLEX MEDICAL INC Teleflex Medical Disposable Aortic Punch, in the following sizes:
a) 2.8 mm, REF DP-28K
b) 3.6 mm, REF DP-36K
c) 4.0 mm, REF DP-40K
d) 4.4 mm, REF DP-44K
e) 4.8 mm, REF DP-48K
f) 5.2 mm, REF DP-52K
g) Terminated |
DWS | None listed |
| Jan 27, 2020 | TELEFLEX MEDICAL INC Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 Terminated |
DWS | None listed |
| Oct 30, 2019 | Teleflex Medical HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronc Terminated |
CBI | K851856 |
| Oct 11, 2019 | TELEFLEX MEDICAL INC Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical
The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting inject Open, Classified |
BSP | K911260 |
| Oct 11, 2019 | TELEFLEX MEDICAL INC Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical
The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting inject Open, Classified |
BSP | K911260 |
| Oct 8, 2019 | Teleflex Medical Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access Open, Classified |
FMI | K141117 |
| Oct 8, 2019 | Teleflex Medical Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access Open, Classified |
FMI | K141117 |
| Oct 8, 2019 | Teleflex Medical Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access Open, Classified |
FMI | K141117 |
| Oct 4, 2019 | Teleflex Medical WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965
Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer l Open, Classified |
FZP | K021808 |
| Oct 4, 2019 | Teleflex Medical WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML
Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips Open, Classified |
FZP | K152084 |
| Sep 9, 2019 | Teleflex Medical Sheridan/HVT Novaplus:
a) 7.0 mm, REF V5-10314
b) 7.5 mm, REF V5-10315
c) 8.0 mm, REF V5-10316
d) 8.5 mm, REF V5-10317
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Sheridan/CF Novaplus 7.0 mm, REF V5-10114
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan/HVT:
a) 5.0 mm, REF 5-10310
b) 5.5 mm, REF 5-10311
c) 6.0 mm, REF 5-10312
d) 6.5 mm, REF 5-10313
e) 7.0 mm, REF 5-10314
f) 7.5 mm, REF 5-10315
g) 8.0 mm, REF 5-10316
h) 8.5 mm, REF Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan Uncuffed:
a) 2.0 mm, REF 5-10404
b) 2.5 mm, REF 5-10405
c) 3.0 mm, REF 5-10406
d) 3.5 mm, REF 5-10407
e) 4.0 mm, REF 5-10408
f) 4.5 mm, REF 5-10409
g) 5.0 mm, REF 5-10410
h) 5.5 Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan Preformed:
a) 3.0 mm, REF 5-22006, REF 5-22106
b) 3.5 mm, REF 5-22007, REF 5-22107
c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208
d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan EZ-ENDO:
a) 5.0 mm, REF 5-22510
b) 5.5 mm, REF 5-22511
c) 7.0 mm, REF 5-22514
d) 7.5 mm, REF 5-22515
e) 8.0 mm, REF 5-22516
f) 8.5 mm, REF 5-22517
g) 9.0 mm, REF 5-22518
h) 6.0 mm, Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan/CF:
a) 3.0 mm, REF 5-10106, REF 5-10206
b) 3.5 mm, REF 5-10107
c) 4.0 mm, REF 5-10108, REF 5-10208
d) 4.5 mm, REF 5-10109
e) 5.0 mm, REF 5-10110, REF 5-10210
f) 5.5 mm, REF 5-1011 Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan LTS:
a) 4.0 mm, REF 5-11108
b) 5.0 mm, REF 5-11110
c) 6.0 mm, REF 5-11112
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Jul 15, 2019 | Teleflex Medical Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column:
a) REF 870-07KIT
b) REF 870-09KIT
Product Usage:
The Neonatal ConchaSmart breathing cir Terminated |
BZE | K173280 |
| Jul 1, 2019 | Teleflex Medical Rusch EasyCath Kit Terminated |
KOD | K000070 |
| Jun 19, 2019 | Teleflex Medical Sheridan/HVT:
1) Novaplus 7.0 mm, Product Code V5-10314
2) Novaplus 7.5 mm, Product Code V5-10315
3) Novaplus 8.0 mm, Product Code V5-10316
4) Novaplus 8.5 mm, Product Code V5-10317
Product Usage:
Tr Terminated |
BTR | K822082 |
| Jun 19, 2019 | Teleflex Medical Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
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