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
89857–89880 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1998
SEGMENTAL DEFECT REPLACEMENT SYSTEM
K980609 · HSB
Metagen, LLC
Orthopedic · 90d
Cleared May 18, 1998
DEXON RAPID (DEXON R)
K980610 · GAM
Davis & Geck, Inc.
General & Plastic Surgery · 90d
Cleared May 18, 1998
CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING...
K980754 · LYY
Crocker Industrial Resources Sdn. Bhd.
General Hospital · 81d
Cleared May 18, 1998
ETEST GREPAFLOXACIN
K980773 · JWY
Ab Biodisk
Microbiology · 77d
Cleared May 18, 1998
PASCO MIC AND MIC/ID PANELS
K980955 · JTN
Pasco Laboratories, Inc.
Microbiology · 66d
Cleared May 18, 1998
ORION VESTA DENTAL ALLOY
K981001 · EJS
European Dental Imports, Inc.
Dental · 61d
Cleared May 18, 1998
ORION WX DENTAL ALLOY
K981002 · EJS
European Dental Imports, Inc.
Dental · 61d
Cleared May 18, 1998
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
K981020 · MID
Zeus Scientific, Inc.
Immunology · 60d
Cleared May 18, 1998
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
K981085 · FIP
Gambro Healthcare
Gastroenterology & Urology · 54d
Cleared May 18, 1998
CA
K981232 · CJY
Abbott Mfg., Inc.
Chemistry · 45d
Cleared May 18, 1998
LD-1
K981338 · JGF
Abbott Laboratories
Chemistry · 35d
Cleared May 18, 1998
SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K981347 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 38d
Cleared May 18, 1998
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
K981348 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 38d
Cleared May 18, 1998
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES
K981349 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 38d
Cleared May 18, 1998
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
K981401 · JJY
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared May 15, 1998
COVERTIP SAFETY SYRINGE
K971077 · MEG
Medisys Technologies, Inc.
General Hospital · 417d
Cleared May 15, 1998
THE SYSTEM 2S STEAM STERILIZER
K980014 · FLE
STERIS Corporation
General Hospital · 133d
Cleared May 15, 1998
VARIOUS SURGICAL OR PATIENT DRAPES
K980210 · KKX
Gel-Lite, LLC
General Hospital · 114d
Cleared May 15, 1998
SITESEER ANGIOGRAPHIC CATHETER
K980575 · DQO
C.R. Bard, Inc.
Cardiovascular · 87d
Cleared May 15, 1998
DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM
K980620 · DZE
Dentatus USA , Ltd.
Dental · 86d
Cleared May 15, 1998
EYE IRRIGATOR MODEL #2020
K980647 · KYG
Eye-Deal Ocular Safety Products, Inc.
Ophthalmic · 87d
Cleared May 15, 1998
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
K980732 · DRY
3M Healthcare
Cardiovascular · 79d
Cleared May 15, 1998
CU-100A LIGHT CURE UNIT
K980792 · EBF
Rolence Enterprise Co. , Ltd.
Dental · 74d
Cleared May 15, 1998
Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
K980793 · EBF
Rolence Enterprise Co. , Ltd.
Dental · 74d