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
89521–89544 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING,...
K981151 · LPN
Alcon Laboratories
Ophthalmic · 84d
Cleared Jun 22, 1998
ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018,...
K981166 · KNW
Inrad
Gastroenterology & Urology · 83d
Cleared Jun 22, 1998
SHARPTRACK REUSABLE SHARPS CONTAINER
K981184 · FMI
Bfi- Medical Waste Systems
General Hospital · 82d
Cleared Jun 22, 1998
HOWMEDICA SCN NAIL
K981261 · HSB
Howmedica Corp.
Orthopedic · 76d
Cleared Jun 22, 1998
NITRILON CORRECT-TOUCH
K981304 · LZA
Ct Intl.
General Hospital · 73d
Cleared Jun 22, 1998
OSTEO I-C HUMERAL NAIL SYSTEM
K981309 · HSB
Osteonics Corp.
Orthopedic · 73d
Cleared Jun 22, 1998
NITRILON CORRECT-TOUCH
K981333 · LZA
Biopro (M) Sdn Bhd
General Hospital · 70d
Cleared Jun 22, 1998
INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM
K981340 · MAI
Innovasive Devices, Inc.
Orthopedic · 70d
Cleared Jun 22, 1998
AMM
K981467 · JIF
Abbott Laboratories
Chemistry · 60d
Cleared Jun 22, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE...
K981670 · HWC
Depuy, Inc.
Orthopedic · 41d
Cleared Jun 22, 1998
O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100
K981724 · GEI
Medtrex, Inc.
General & Plastic Surgery · 38d
Cleared Jun 22, 1998
ALKP
K981806 · CJE
Abbott Laboratories
Chemistry · 32d
Cleared Jun 22, 1998
HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
K981893 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 24d
Cleared Jun 22, 1998
MRS-400, MAXI 400, MRSL-400, MAXI 400L
K981990 · EFB
D.B.I. America Corp.
Dental · 14d
Cleared Jun 19, 1998
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
K973013 · LIT
Vas-Cath, Inc.
Cardiovascular · 310d
Cleared Jun 19, 1998
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM
K980728 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 114d
Cleared Jun 19, 1998
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K980873 · LMA
Konica Corp.
Radiology · 105d
Cleared Jun 19, 1998
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
K981286 · KDH
Armm, Inc.
Gastroenterology & Urology · 72d
Cleared Jun 19, 1998
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
K981328 · MOB
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Jun 19, 1998
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
K981330 · MOB
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Jun 19, 1998
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
K981470 · IZH
Worldwide Medical Technologies, LLC
Radiology · 57d
Cleared Jun 19, 1998
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K981621 · LTZ
Suretex Prophylactics (India) , Ltd.
Obstetrics & Gynecology · 44d
Cleared Jun 19, 1998
URIC ACID
K981766 · CDO
Abbott Laboratories
Chemistry · 31d
Cleared Jun 18, 1998
DURACON(R) SMALL STABILIZER TIBIAL INSERT
K974843 · JWH
Howmedica Corp.
Orthopedic · 176d