FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89353–89376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 15, 1998
CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
K981000 · EIH
European Dental Imports, Inc.
Dental · 58d
Cleared May 15, 1998
MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK
K981073 · FYA
Medcom Laundry Service, Inc.
General Hospital · 52d
Cleared May 15, 1998
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES
K981179 · LZA
Lovytex Sdn Bhd
General Hospital · 44d
Cleared May 14, 1998
BARD ISOFLOW BLOOD PUMP
K971421 · DWA
C.R. Bard, Inc.
Cardiovascular · 393d
Cleared May 14, 1998
STARDUST
K973920 · MNR
Respironics, Inc.
Anesthesiology · 211d
Cleared May 14, 1998
MICRO-PLATE COTININE EIA
K974234 · MKU
OraSure Technologies, Inc.
Toxicology · 183d
Cleared May 14, 1998
FRESENIUS F SERIES HEMOCONCENTRATORS...
K974584 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 157d
Cleared May 14, 1998
CAPIOX SX HARDSHELL RESERVOIR
K980935 · DTN
Terumo Medical Corp.
Cardiovascular · 63d
Cleared May 14, 1998
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE...
K981239 · FZP
Deroyal Surgical
General & Plastic Surgery · 41d