Company · US
Sterilmed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2026. Name variants (Inc, Corp, punctuation) are merged.
65510(k) clearances (1 in 12 months)
41recalls (2 in 12 months)
24recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 11 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 10 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 9 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 9 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 6 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 |
| NLF | Oximeter, Reprocessed | 4 |
| JOW | Sleeve, Limb, Compressible | 3 |
| KCY | Tourniquet, Pneumatic | 3 |
| NMF | Clamp, Vascular, Reprocessed | 3 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| GEX | Powered Laser Surgical Instrument | 2 |
| JOS | Electrode, Electrosurgical | 2 |
| NKU | Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed | 2 |
| NKX | Needle, Phacoemulsification, Reprocessed | 2 |
| NLL | Staple, Implantable, Reprocessed | 2 |
| NLU | Forceps, Biopsy, Electric, Reprocessed | 2 |
| NLW | Electrode, Electrosurgical, Active, Urological, Reprocessed | 2 |
| NML | Catheter, Biliary, Reprocessed | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2026 | K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CR Sterilmed, Inc. | OWQ |
| Oct 11, 2024 | K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter Sterilmed, Inc. | NLH |
| Nov 14, 2019 | K190478 | Reprocessed ViewFlex Xtra ICE Catheter Sterilmed, Inc. | OWQ |
| Aug 15, 2019 | K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Sterilmed, Inc. | NLQ |
| Apr 15, 2019 | K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis Sterilmed, Inc. | NLQ |
| Nov 21, 2016 | K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters Sterilmed, Inc. | OWQ |
| Sep 20, 2016 | K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Te Sterilmed, Inc. | NUJ |
| Jun 23, 2016 | K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter Sterilmed, Inc. | NLH |
| Mar 23, 2016 | K152090 | Reprocessed Steerable Introducer Sterilmed, Inc. | PNE |
| Jan 15, 2016 | K152134 | Reprocessed Vessel Sealer Sterilmed, Inc. | NUJ |
| Aug 27, 2015 | K150357 | Reprocessed Electrophysiology Diagnostic Catheters Sterilmed, Inc. | NLH |
| May 20, 2015 | K143562 | Reprocessed Cordless Ultrasonic Dissection Device Sterilmed, Inc. | NLQ |
| Feb 23, 2015 | K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider Sterilmed, Inc. | NUJ |
| Jun 14, 2014 | K132566 | REPROCESSED HARMONIC SHEAR Sterilmed, Inc. | NLQ |
| Jan 22, 2014 | K133414 | REPROCESSED CLOSURE SYSTEM Sterilmed, Inc. | NLM |
| Jan 25, 2013 | K123096 | REPROCESSED VESSEL SEALER Sterilmed, Inc. | NUJ |
| Oct 5, 2012 | K120040 | REPROCESSED SURGICAL ELECTRIC INSTRUMENT Sterilmed, Inc. | NUJ |
| Aug 6, 2012 | K121158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. | NLH |
| Jun 11, 2012 | K121240 | REPROCESSED ENDOSCOPIC TROCARS Sterilmed, Inc. | NLM |
| Apr 3, 2012 | K120204 | REPROCESSED FEMORAL COMPRESSION DEVICE Sterilmed, Inc. | NMF |
| Jan 11, 2012 | K111794 | REPROCESSED HARMONIC SCALPEL Sterilmed, Inc. | NLQ |
| Aug 18, 2011 | K110076 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER Sterilmed, Inc. | OWQ |
| Jul 18, 2011 | K111002 | REPROCESSED ENDOSCOPIC TROCARS Sterilmed, Inc. | NLM |
| Feb 18, 2011 | K102560 | REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. | NLF |
| Aug 19, 2010 | K101789 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. | NLH |
| Jun 25, 2010 | K100707 | REPROCESSED PINS Sterilmed, Inc. | NDM |
| Jan 14, 2010 | K092158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. | NLH |
| Nov 3, 2009 | K092368 | REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. | NLF |
| Mar 2, 2009 | K083636 | REPROCESSED EXTERNAL FIXATION DEVICE Sterilmed, Inc. | KTT |
| Jan 9, 2009 | K083060 | REPROCESSED HARMONIC SCALPEL Sterilmed, Inc. | NLQ |
| Dec 17, 2008 | K081814 | REPROCESSED ENT SHAVERS Sterilmed, Inc. | ERL |
| Aug 18, 2008 | K081586 | REPROCESSED EXTERNAL FIXATION DEVICE Sterilmed, Inc. | KTT |
| Aug 13, 2008 | K081342 | REPROCESSED EXTERNAL FIXATION ACCESSORIES Sterilmed, Inc. | KTT |
| Feb 12, 2008 | K073613 | REPROCESSED SCISSOR TIPS Sterilmed, Inc. | NUJ |
| Oct 18, 2007 | K070930 | REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS Sterilmed, Inc. | NLL |
| Sep 12, 2007 | K070859 | REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS Sterilmed, Inc. | NLL |
| Mar 15, 2007 | K063844 | REPROCESSED HEART STABILIZERS AND POSITIONERS Sterilmed, Inc. | NQG |
| May 23, 2006 | K052299 | REPROCESSED ENDOSCOPIC TROCAR Sterilmed, Inc. | NLM |
| May 4, 2006 | K053188 | REPROCESSED BALOON INFLATION DEVICE Sterilmed, Inc. | NKU |
| Jul 20, 2005 | K050136 | REPROCESSED HOT BIOPSY FORCEPS Sterilmed, Inc. | NLU |
| Jul 20, 2005 | K042648 | REPROCESSED COLD BIOPSY FORCEPS Sterilmed, Inc. | NON |
| Jun 14, 2005 | K051220 | REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. | NLH |
| May 23, 2005 | K043592 | REPROCESSED ENDOSCOPIC TROCAR Sterilmed, Inc. | NLM |
| Apr 12, 2005 | K050343 | REPROCESSED HARMONIC SCALPELS Sterilmed, Inc. | NLQ |
| Mar 1, 2005 | K043513 | STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER Sterilmed, Inc. | NLH |
| Mar 1, 2005 | K043453 | STERILEMED REPROCESSED IVUS IMAGING CATHETER Sterilmed, Inc. | OWQ |
| Sep 23, 2004 | K041127 | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS Sterilmed, Inc. | NLF |
| Mar 28, 2003 | K012677 | REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. | NLF |
| Oct 11, 2002 | K012537 | REPROCESSED IMAGING CATHETERS Sterilmed, Inc. | OWQ |
| Aug 14, 2002 | K012678 | REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. | NLH |
Newest 50 of 65.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2025 | Sterilmed, Inc. Brand Name: Sterilmed Reprocessed Imaging Catheter
Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM
Model/Catalog Number: ACU10135936
Software Version: N/A
P Open, Classified |
OWQ | K043453 |
| Nov 20, 2025 | Sterilmed, Inc. Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM
Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM
Model/Catalog Numb Open, Classified |
OWQ | K043453 |
| Oct 9, 2018 | Sterilmed, Inc. Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart.
(a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309;
(b) me Terminated |
PNH | K152090 |
| Dec 29, 2017 | Sterilmed Inc St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single u Terminated |
DYB | K152090 |
| May 8, 2017 | Sterilmed Inc Electrophysiology catheter cables are designed
as electrode cables with a multi-pin connector on
the distal end and the appropriate number of tails
on the proximal end. The cables serve two
differ Terminated |
N/A | None listed |
| May 31, 2016 | STERILMED, INC. Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and Terminated |
NUJ | K073613 |
| Nov 13, 2015 | STERILMED, INC. Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only. Terminated |
KCY | None listed |
| Sep 28, 2015 | STERILMED, INC. Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed.
Products are individually packaged Terminated |
KCY | None listed |
| Oct 9, 2014 | STERILMED, INC. Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. Terminated |
OWQ | K110076 |
| Jan 13, 2009 | Sterilmed Inc Reamers
Model #'s:
HAL5091-144 and
ZIMS5979-95-41
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other d Terminated |
HTO | None listed |
| Jan 13, 2009 | Sterilmed Inc Taps
Model #'s:
SYN311.15
SYN311.190
SYN311.39 and
SYN311.32
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use w Terminated |
HWX | None listed |
| Jan 13, 2009 | Sterilmed Inc Biopsy Forceps, Cold
Model #'s:
BAR000386
BAR000388
MIC1012
MIC1331
MIC1333
MIC1337
MIC1536
MIC1589
MIC1597
MIC1598 and
MIC1599
The Reprocessed Cold Biopsy Forceps are intended to be used during endo Terminated |
NON | K042648 |
| Jan 13, 2009 | Sterilmed Inc Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suite Terminated |
FWZ | None listed |
| Jan 13, 2009 | Sterilmed Inc TURP Electrodes
Model #'s:
CIRMLE-24-012
CIRMLE-24-015
OLYA22205C
STO27050F
STO27050G and
STO27050NK
Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation Terminated |
NLW | K012685 |
| Jan 13, 2009 | Sterilmed Inc Tourniquet Cuffs
Model #'s:
INSDT-7024-02
INSDT-7218-01
SMI553322
SMI7010-7002
SMI7010-7006
SMI7010-7007
SMI7010-7008
SMI7010-7010
SMI7010-7011
SMI7010-7012
SMI7010-7015
STR5921-018-136
STR5921-018-2 Terminated |
KCY | None listed |
| Jan 13, 2009 | Sterilmed Inc Stone Retrieval Basket Model #': BOS390-105
Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures. Terminated |
FFL | K012581 |
| Jan 13, 2009 | Sterilmed Inc Scissor Tips
Model #'s:
AESPO888
AESPO889
ENCES0102
MIC3112
MIC3122
MIC3142
MIC3152
SNO89-5100 and
SNO89-5300
Intended to be used with a resusable hand piece and are designed to use in minimally inv Terminated |
NUJ | K073613 |
| Jan 13, 2009 | Sterilmed Inc Saw Blade
Model #'s:
BIO506112
BIO506113
DEP2555-91-000
DEP5627-11-500
HAL5023-118
HAL5059-32
HAL5071-133
HAL5071-145
HAL5071-163
HAL5071-181
HAL5071-572
HOWHB-NST-6828-7-791
HOWHB-NST-6828-7-792
KOM Terminated |
GFA | None listed |
| Jan 13, 2009 | Sterilmed Inc RF Arthroscopy Probe
Model #'s:
ARTA1325-01
ARTA1335-01
ARTA1345-01
ARTA1730-01
ARTA2630-01
ARTA3625-01
ARTA4330-01
ARTAS1335-01
ARTAS4630-01
ARTASC1335-01
ARTASC2530-01
ARTASC4250-01
ARTASC4830-01 Terminated |
GEI | K012679 |
| Jan 13, 2009 | Sterilmed Inc Retractors
Model #'s:
ADE3204
BOS820-175
LON3304 and
LON3334-4G
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, i Terminated |
GAD | None listed |
| Jan 13, 2009 | Sterilmed Inc Rasps
Model #'s:
KOMKM5100-37-113
KOMKM-82
STR1675-115
STR5100-37-113 and
STR5100-37-115
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, eithe Terminated |
HTR | None listed |
| Jan 13, 2009 | Sterilmed Inc Phaco Tips
Model #'s:
ALC30RTS
ALC8065740806
ALC8065740809
ALC8065740837
ALC8065740839
ALC8065750852
ALC8065790020
ALC8065790022 and
ALLOPOR3020L
Intended use of this device is to assist in the auto Terminated |
NKX | K012579 |
| Jan 13, 2009 | Sterilmed Inc Multi-Clip Applier
Model #'s:
APPCA080
AUT134031
AUT134046
AUT134051
AUT134053
AUT176625
AUT176657
AUTPTACK30
ETHEL5ML
ETHER320
ETHMCL20
ETHMCM20
ETHMCM30
ETHMCS20
ETHMSM20 and
WEC543965
A manual Terminated |
HBT | None listed |
| Jan 13, 2009 | Sterilmed Inc Masks - Laryngeal
Model #'s:
AMB321-300-000
AMB321-400-000
AMB321-500-000
LMA12015
LMA12020
LMA12030
LMA12040
LMA12050
LMA12120
LMA12125
LMA12130
LMA12140 and
LMA21140
An oropharyngeal airway is a de Terminated |
CAE | None listed |
| Jan 13, 2009 | Sterilmed Inc Laser Probe Model #': SYN55.26.25
Reprocessed laser probes are part of a laser delivery system and are used in opthalmic procedures where laser energy is the mode of treatment. Terminated |
GEX | K012682 |
| Jan 13, 2009 | Sterilmed Inc Lap Instruments/Graspers/Forceps - COLD
Model #'s:
AUT173030
AUT174233
AUT174317
AUT176613
AUT176647
AUTECATCH10G and
ETH5DSG
A manual surgical instrument for general use is a nonpowered, hand-held, Terminated |
GDI | None listed |
| Jan 13, 2009 | Sterilmed Inc Lap Instruments/Graspers/Forceps - HOT
Model #'s:
AUT173016
AUT174301
AUT176643
AUT176643
ETH5DCD
ETH5DCS
ETHEBF01
ETHPOUCH
GYR3000PK
GYR3005PK
GYR3640 and
GYR920005PK
Laparoscopic electric instru Terminated |
NUJ | K012598 K050136 |
| Jan 13, 2009 | Sterilmed Inc Harmonic Scalpel
Model #'s:
ETHACE14S
ETHACE23P
ETHACE36P
ETHCS14C
ETHFCS9
ETHHDH05
ETHLCS-C5 and
ETHLCSC5HA
Intended for use in soft tissue incisions when bleeding control and minimal thermal inju Terminated |
NLQ | K012571 K050343 |
| Jan 13, 2009 | Sterilmed Inc Guidewires - Endoscopic (Jag Wires)
Model #'s:
MIC5658 and
MIC630-100
Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, ri Terminated |
NML | K012556 |
| Jan 13, 2009 | Sterilmed Inc Femoral Compression Device
Model #'s:
RAD11163
Intended for use in the compression of the femoral artery or vein after cauterization. Terminated |
NMF | K012574 |
| Jan 13, 2009 | Sterilmed Inc External Fixation Device
Model #'s:
ORT99-36501
SYN390.005
SYN390.008
SYN394.84
SYN394.85 and
SYN394.86
Intended for use in the construction of an external fixation frame for treatment of a various f Terminated |
KTT | K051957 |
| Jan 13, 2009 | Sterilmed Inc EP Catheter
Model #'s:
BIOD6-DR-005-RT
BIOD6-DR-010-RT
DAI401381
DAI401449
DAI401904
DAI401915 and
EPT7003D
Intended for temporary use during electrophysiology studies for intracardiac sensing, reco Terminated |
NLH | K012523 K012678 +2 |
| Jan 13, 2009 | Sterilmed Inc EP Cables
Model #'s:
BAR560004P
BIOC10MR10MSTKS
BIOC5-MH/NAVMH-S
CORC6-MR10/EPTR-S
DAI401972
DAI401976
DAI401977
DAI401981
DAI401983
EPT5454S
EPT613 and
EPT651
An electrode cable is a device compose Terminated |
IKD | None listed |
| Jan 13, 2009 | Sterilmed Inc Compression Sleeves
Model #'s:
HUNDVT10-1 and
KEN5329
The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is a Terminated |
JOW | K003857 |
| Jan 13, 2009 | Sterilmed Inc Colorado Electrodes
Model #'s:
COLN104A
COLN112A and
STRN103A
Intended for precision cutting or dissecting and cauterizing soft tissue. Terminated |
JOS | K012684 |
| Jan 13, 2009 | Sterilmed Inc Cardiac Imaging Catheter
Model #'s:
ACU08267996 and
ACU55790
Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great ves Terminated |
NLI | K043453 |
| Jan 13, 2009 | Sterilmed Inc Burrs
Model #'s:
ANSL-3SB
ANSL-5D
ANSQD11-4OVDC
HAL5056-118
HAL5056-166
HAL5091-106
HAL5091-112
HAL5091-122
HAL5091-125
HAL5091-136
HAL5091-144
HAL5091-164
HAL5092-120
HAL5092-168
HAL5092-170
KOM04- Terminated |
GFF | None listed |
| Jan 13, 2009 | Sterilmed Inc Biopsy Forceps, Hot
Model #'s:
BAL60110
BAR000852
BAR000854 and
MIC1550
Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilit Terminated |
NLU | K050343 |
| Jan 13, 2009 | Sterilmed Inc Drill Bits
Model #'s:
DEP14043
MIC8053-019
RIC21-0438
RIC21-0439
RIC21-0441
RIC21-0442
RIC71173504
RIC71173505
RIC71631117
SMI21-0445
STR5800-4-125
STR60-13570
SYN03.010.060
SYN03.010.061
SYN03.010.1 Terminated |
HTW | None listed |
| Jan 13, 2009 | Sterilmed Inc Bed Check
Model #'s:
BED65815-021
BED65815-025
BED65815-025IT
BED65815-030
BED65815-031
BED73000
BED73010
BED74000
BED74010
NURBPP-30A
NURBPP-30WC
POS8283
RFT1000-1210
RFT1000-1250
RFT1000-1810 and
R Terminated |
KMI | None listed |
| Jan 13, 2009 | Sterilmed Inc Balloon Inflation Device
Model #'s:
MED15-105
MED15-106 and
SCI04527-01
The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressur Terminated |
NKU | K053188 |