Company · US
Covidien LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
225510(k) clearances (8 in 12 months)
576recalls (13 in 12 months)
502recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GDW | Staple, Implantable | 96 |
| MSD | Catheter, Hemodialysis, Implanted | 74 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 55 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 32 |
| GCJ | Laparoscope, General & Plastic Surgery | 31 |
| NYU | Catheter, Hemodialysis, Implanted, Coated | 31 |
| NGT | Saline, Vascular Access Flush | 28 |
| CBK | Ventilator, Continuous, Facility Use | 27 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 27 |
| GAP | Suture, Nonabsorbable, Silk | 25 |
| EZL | Catheter, Retention Type, Balloon | 24 |
| KOD | Catheter, Urological | 17 |
| NEY | System, Ablation, Microwave And Accessories | 16 |
| FSY | Light, Surgical, Ceiling Mounted | 14 |
| LRS | I.V. Start Kit | 14 |
| DQA | Oximeter | 12 |
| JOH | Tube Tracheostomy And Tube Cuff | 11 |
| JOW | Sleeve, Limb, Compressible | 11 |
| KOY | Degreaser, Skin, Surgical | 10 |
| NAD | Dressing, Wound, Occlusive | 9 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2026 | K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated Covidien, LLC | GEI |
| Aug 13, 2026 | K260907 | BIS Advance pEEG Module Covidien LP | OLW |
| Jul 1, 2026 | K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Th Covidien, LLC | GAG |
| Jun 4, 2026 | K253984 | Instrument Exit Point on Touch Surgery Aide Covidien, LLC | SFE |
| May 1, 2026 | K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) Covidien, LLC | CCK |
| Dec 29, 2025 | K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Covidien, LLC | JOH |
| Dec 29, 2025 | K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) Covidien, LLC | BZT |
| Dec 3, 2025 | K250725 | Hugo RAS System Covidien, LLC | SCV |
| Oct 6, 2025 | K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-X Covidien, LLC | BTR |
| Sep 25, 2025 | K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Re Covidien, LLC | BTR |
| Dec 3, 2024 | K241486 | Sofsilk Coated Braided Silk Suture Covidien | GAP |
| Aug 20, 2024 | K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) Covidien | FLL |
| Jul 12, 2024 | K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) Covidien, LLC | GEI |
| Jul 1, 2024 | K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Penc Covidien, LLC | GEI |
| May 20, 2024 | K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465 Covidien, LLC | BTR |
| Feb 26, 2024 | K230693 | BIS Advance Monitoring System Covidien, LLC | OLW |
| Oct 27, 2023 | K231934 | GIA Stapler with Tri-Staple Technology Covidien, CN | GAG |
| Sep 8, 2023 | K231240 | MaxTack Motorized Fixation Device Covidien | OCW |
| Aug 30, 2023 | K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150 Covidien | BTR |
| Aug 16, 2023 | K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil Covidien, CN | GAG |
| Aug 16, 2023 | K231491 | TA Stapler and Loading Unit with DST Series Technology Covidien | GAG |
| Jul 21, 2023 | K231861 | EndoflipTM 300 System Covidien, LLC | FFX |
| Apr 14, 2023 | K223705 | EndoflipTM 300 Covidien, LLC | FFX |
| Feb 22, 2023 | K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) Covidien | GAG |
| Jan 23, 2023 | K223158 | LigaSure XP Maryland Jaw Sealer/Divider Covidien, LLC | GEI |
| Nov 30, 2022 | K221771 | EEA Circular Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Nov 29, 2022 | K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip Version Covidien | GDW |
| Sep 30, 2022 | K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series T Covidien | GDW |
| Sep 22, 2022 | K220540 | ProGrip Self-Gripping Polypropylene Mesh Covidien | FTL |
| Jul 29, 2022 | K213911 | Microstream CO2 NanoPod Covidien, LLC | CCK |
| Jun 27, 2022 | K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula Covidien | GCJ |
| Jun 13, 2022 | DEN220006 | ProdiGI Covidien, LLC | QSW |
| May 6, 2022 | K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC Covidien, LLC | DQA |
| May 5, 2022 | K221013 | GIA Auto Suture Stapler with DST Series Technology Covidien | GDW |
| Apr 29, 2022 | K221006 | GIA Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Apr 29, 2022 | K221005 | EEA Circular Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Apr 12, 2022 | K213518 | CARESCAPE CO2 Microstream parameter Covidien, LLC | CCK |
| Feb 25, 2022 | K203150 | Cool-tip RF Ablation System E Series Covidien, LLC | GEI |
| Jan 14, 2022 | K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit Covidien, LLC | FJS |
| Dec 5, 2021 | K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as Covidien, LLC | MUD |
| Nov 15, 2021 | K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device Covidien, LLC | LFL |
| Sep 17, 2021 | K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector Covidien | CCK |
| Apr 15, 2021 | K210338 | Edge Insulated Blade Electrode Covidien, LLC | GEI |
| Mar 23, 2021 | K202917 | LigaSure Exact Dissector, Nano-coated Covidien, LLC | GEI |
| Jan 21, 2021 | K202507 | EEA Circular Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Jan 9, 2021 | K202874 | Puritan Bennett Cuff Pressure Manager Covidien, LLC, CN | BSK |
| Dec 17, 2020 | K203303 | Emprint SX Ablation Platform with Thermosphere Technology Covidien, LLC | NEY |
| Dec 7, 2020 | K202701 | GIA Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Nov 20, 2020 | K193056 | Puritan Bennett 980 Series Ventilator System Covidien, LLC | CBK |
| Oct 28, 2020 | K202864 | Tri-Staple 2.0 Reloads Covidien | GDW |
Newest 50 of 225.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Covidien, LLC EndoFLIP System that includes:
ENDOFLIP 1 SYSTEM EF-100
05391530810050
10884521809307
REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1
10884521808096
05391530810166
DL ENDOFLIP 1
10884521786684 Open, Classified |
FFX | K183072 |
| Aug 7, 2026 | Covidien, LP Surgipro II
S8698GX SURGIPRO II BL 5/0 18 P-13
S8698GX Open, Classified |
GAW | K050947 |
| Aug 7, 2026 | Covidien, LP Surgipro
SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36
SP-623 Open, Classified |
GAW | None listed |
| Aug 7, 2026 | Covidien, LP Dermalon
88861757-31 DERMALON* 4-0 BLU 75CM C13
88861757-31
88861799-31 DERMALON* 4-0 BLU 75CM C14
88861799-31 Open, Classified |
GAR | K981582 |
| Aug 7, 2026 | Covidien, LP V-Loc 180 Absorbable Wound Closure Device
BOX BEDSIDE STAPLING IS KING
BOX06614V4
BOX BY PASS FINAL
BOX07405V1
BOX BYPASS CARDON
BOX01056V2
BOX BYPASS DR LAGAE
BOX01482V2
BOX BYPASS Open, Classified |
GAM | K091087 K093408 |
| Aug 7, 2026 | Covidien, LP V-Loc 90 Absorbable Wound Closure Device
VLOC 90 0 VL 22 GS-21
VLOCM0336
VLOC 90 0 VL 22 GS-25 VLOCM0436
VLOCM0436
VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12
VLOCM0003
VLOCM0013 V-LOC* 90 4- Open, Classified |
GAM | K100257 |
| Jul 2, 2026 | Covidien LLC Covidien Shiley Disposable Decannulation Plug
REF
DDCP
UDI-DI code: 10884522004060
Product Codes that include the Covidien Shiley Disposable Decannulation Plug are:
Product Number / UDI-DI code
4DCF Open, Classified |
BTO | K843730 |
| Jun 1, 2026 | Covidien, LP Covidien EndoStitch" Polysorb Single Use Loading Unit;
Product numbers: 170053 and 170071; Open, Classified |
OCW | K934738 |
| May 29, 2026 | Covidien LLC Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr
REF: 90050 Open, Classified |
BZT | None listed |
| May 29, 2026 | Covidien LLC Covidien Mon-a-Therm General Purpose Temperature Probe
REF: 90044 Open, Classified |
BZT | None listed |
| May 29, 2026 | Covidien LLC Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM
REF: 90042 Open, Classified |
BZT | None listed |
| May 29, 2026 | Covidien LLC COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN
UDI-DI code: 60884522007028
The devices are intended for use in providing tracheal access for airway management. Shiley Tracheost Open, Classified |
JOH | K812302 |
| Mar 11, 2026 | Covidien LLC HealthCast "Vital Sync" Remote Patient Monitoring System which consists of:
Product Number:
VSLBASE03P / VITALSYNCSW03
Model / UDI-DI codes:
Vital Sync 3.3.1 / 10884521844933
Vital Sync 3.4.0 / 108845 Open, Classified |
MWI | K160718 |
| Nov 7, 2025 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin);
BOX LOBECTOMIA VATS 3D;
CFN: BOX06170V4; Open, Classified |
GDW | K191070 |
| Nov 7, 2025 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin);
CFN: SIGSDL45CTVT; Open, Classified |
GDW | K191070 K222641 |
| Jul 21, 2025 | Covidien Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941,
10005941J, 10005941JP, 10005941JPN Open, Classified |
DQA | K120773 K142865 |
| Jun 9, 2025 | Covidien Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU.
Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70 Open, Classified |
CBK | K111146 |
| Mar 25, 2025 | Covidien Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R Open, Classified |
JOH | K150844 |
| Oct 29, 2024 | Covidien LP Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US Open, Classified |
LIT | K163231 |
| Aug 22, 2024 | Covidien Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly Open, Classified |
CCW | None listed |
| Aug 21, 2024 | Covidien McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only Open, Classified |
CCW | None listed |
| Aug 21, 2024 | Covidien McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only Open, Classified |
CCW | None listed |
| Aug 2, 2024 | Covidien Puritan Bennett 500 Series Ventilators (Description/REF):
PURITAN BENNETT 560 VENTILATOR/4096600,
PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01,
PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02,
P Open, Classified |
CBK | K070899 |
| Jun 7, 2024 | Covidien, LLC EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only Open, Classified |
PID | K132337 |
| May 24, 2024 | Covidien, LP Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal,
gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis
Model: SIGTR Open, Classified |
GDW | K173270 |
| Apr 30, 2024 | Covidien Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC Open, Classified |
MUD | K182868 |
| Apr 30, 2024 | Covidien Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC Open, Classified |
MUD | K211561 |
| Apr 29, 2024 | Covidien, LP Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation. Open, Classified |
GAP | K981128 |
| Apr 24, 2024 | Covidien LP Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion Open, Classified |
MSD | K123196 |
| Apr 24, 2024 | Covidien LP Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialy Open, Classified |
MSD | K123196 |
| Apr 3, 2024 | Covidien, LP Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL Open, Classified |
GCJ | K924011 |
| Apr 3, 2024 | Covidien, LP Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT Open, Classified |
GCJ | K924011 |
| Apr 3, 2024 | Covidien, LP Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS Open, Classified |
GCJ | K924011 |
| Apr 3, 2024 | Covidien, LP Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT Open, Classified |
GCJ | K924011 |
| Apr 3, 2024 | Covidien, LP Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL Open, Classified |
GCJ | K924011 |
| Apr 3, 2024 | Covidien, LP Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL Open, Classified |
GCJ | K924011 |
| Apr 3, 2024 | Covidien, LP Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB Open, Classified |
GCJ | K924011 |
| Apr 1, 2024 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Open, Classified |
GDW | K191070 |
| Apr 1, 2024 | Covidien, LP Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Open, Classified |
GDW | K191070 |
| Mar 21, 2024 | Covidien Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 Open, Classified |
GDY | None listed |
| Feb 6, 2024 | Covidien LP AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm-
-intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures
Mo Open, Classified |
OCW | K090470 |
| Jan 29, 2024 | Covidien LP Sofsilk Braided Silk sutures:
CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36
GS-831 SOFSILK* 4-0 BLK 75CM V20 X36
S-176 SOFSILK* 0 BLK 12X45CM PCT X24
S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36
S-184 SOFSILK* 3- Open, Classified |
GAP | K981128 |
| Jan 29, 2024 | Covidien LP Surgilon Braided Nylon sutures:
88861919-31 SURGILON* 4-0 BLK 7X75CMPCT
88861919-41 SURGILON* 3-0 BLK 7X75CMPCT
88861919-51 SURGILON* 2-0 BLK 7X75CMPCT
88861919-71 SURGILON* 1 BLK 7X75CM PCT Open, Classified |
GAR | K981582 |
| Jan 3, 2024 | Covidien Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD Open, Classified |
GEI | K191601 |
| Nov 2, 2023 | Covidien Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 Open, Classified |
CCW | None listed |
| Nov 1, 2023 | Covidien McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only Open, Classified |
CCW | None listed |
| Nov 1, 2023 | Covidien McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only Open, Classified |
CCW | None listed |
| Sep 29, 2023 | Covidien Puritan Bennett Cuff Pressure Manager, REF: 180-03 Open, Classified |
BSK | K202874 |
| Sep 25, 2023 | Covidien LP Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Open, Classified |
MSD | K111372 |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit
REF: 8888345637HP Open, Classified |
NIE | K020089 K102605 |
Newest 50 of 576.