FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93073–93096 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1997
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
K971571 · KDN
Waters Instruments, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 29, 1997
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K971597 · NAE
Coloplast Corp.
General & Plastic Surgery · 89d
Cleared Jul 29, 1997
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
K971671 · HLI
Heidelberg Engineering
Ophthalmic · 83d
Cleared Jul 29, 1997
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
K971687 · FJK
National Medical Care, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 29, 1997
VG 200 VIDEO GASTROSCOPE
K971734 · FDS
Welch Allyn, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 29, 1997
WELCON HUE-VU URINARY DRAINAGE BAG
K971764 · KNX
Welcon, Inc.
Gastroenterology & Urology · 77d
Cleared Jul 29, 1997
BONE AND MARROW COLLECTION SYSTEM KIT
K971782 · GEY
Biomedical Ent., Inc.
General & Plastic Surgery · 76d
Cleared Jul 29, 1997
MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
K971916 · MDA
Medical Z, S.A.
General & Plastic Surgery · 67d
Cleared Jul 29, 1997
STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION...
K972069 · FQH
Stryker Instruments
General Hospital · 56d
Cleared Jul 29, 1997
MYRINGOTOMY TUBE
K972126 · ETD
Mednet Locator, Inc.
Ear, Nose, Throat · 54d
Cleared Jul 29, 1997
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972177 · LZA
Absolute Synthetic Technologies...
General Hospital · 49d
Cleared Jul 29, 1997
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972195 · LZA
Absolute Synthetic Technologies...
General Hospital · 48d
Cleared Jul 29, 1997
VISTA UNIVERSAL HANDPIECE
K972252 · HQC
Odyssey Technologies, Inc.
Ophthalmic · 43d
Cleared Jul 29, 1997
P3 UNIVERSAL PHACO HANDPIECE
K972253 · HQC
Odyssey Technologies, Inc.
Ophthalmic · 43d
Cleared Jul 29, 1997
GALLINI COAXIAL INTRODUCER
K972266 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 42d
Cleared Jul 29, 1997
LASER PERIPHERALS HOLMIUM BARE FIBERS
K972272 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 41d
Cleared Jul 29, 1997
DERMAMEND HYDROGEL GAUZE DRESSING
K972336 · KMF
Dermarx Corp.
General & Plastic Surgery · 36d
Cleared Jul 29, 1997
OVATION HDP
K972373 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 29, 1997
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND...
K972672 · ITX
Barzell-Whitmore Maroon Bells, Inc.
Radiology · 13d
Cleared Jul 28, 1997
FIRST MEDIC PULSE OXIMETRY MODULE
K955890 · MKJ
Colorado Medtech, Inc.
Cardiovascular · 577d
Cleared Jul 28, 1997
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
K963777 · KPJ
Stephenson Industries, Inc.
General & Plastic Surgery · 311d
Cleared Jul 28, 1997
A-V IMPULSE SYSTEM MODEL 6060
K964425 · JOW
Powell,Goldstein,Frazer & Murphy
Cardiovascular · 265d
Cleared Jul 28, 1997
CARD GUARD, MODEL CG-7100
K964836 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 241d
Cleared Jul 28, 1997
MM-1 MOVEMENT MONITOR
K971318 · GYD
Axon Instruments, Inc.
Neurology · 110d