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
84625–84648 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1999
SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
K992953 · KGO
Ansell Perry
General Hospital · 58d
Cleared Oct 29, 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
K993091 · FGE
Cordis Corp.
Gastroenterology & Urology · 43d
Cleared Oct 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
K993093 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 43d
Cleared Oct 29, 1999
POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING...
K993287 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 28d
Cleared Oct 29, 1999
QUICKSTRIP ONE STEP OPIATES TEST
K993490 · DJG
Syntron Bioresearch, Inc.
Toxicology · 14d
Cleared Oct 29, 1999
QUICKPAC II ONE STEP OPIATES TEST
K993491 · DJG
Syntron Bioresearch, Inc.
Toxicology · 14d
Cleared Oct 28, 1999
SERAQUEST EB VCA IGG
K990410 · LSE
Quest Intl., Inc.
Microbiology · 261d
Cleared Oct 28, 1999
DUAL LUMEN CATHETER, MODEL DL-35-90
K991601 · DQY
Endologix, Inc.
Cardiovascular · 171d
Cleared Oct 28, 1999
SPRING-WOUND EPIDURAL CATHETER
K991879 · BSO
Micor, Inc.
Anesthesiology · 148d
Cleared Oct 28, 1999
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
K992169 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 122d
Cleared Oct 28, 1999
CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS...
K993245 · DYG
Alba Critical Care, Ltd.
Cardiovascular · 30d
Cleared Oct 28, 1999
PROWLER PLUS INFUSION CATHETER
K993266 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 28d
Cleared Oct 28, 1999
K-ASSAY APO B
K993354 · DER
Kamiya Biomedical Co.
Chemistry · 23d
Cleared Oct 27, 1999
CRICOTHYROTOMY TUBE
K983000 · BTO
Polamedco, Inc.
Anesthesiology · 426d
Cleared Oct 27, 1999
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
K983613 · LYZ
Shanghai Jiatai Plastic Products Co.,...
General Hospital · 378d
Cleared Oct 27, 1999
OXYCONALPHA WITH OPTION ECG
K984465 · LOS
Erich Jaeger B.V.
Cardiovascular · 315d
Cleared Oct 27, 1999
ST-302 INFRAREX
K990233 · ILY
Skylark Device Co., Ltd.
Physical Medicine · 275d
Cleared Oct 27, 1999
ELECTRIC MOBILITY CAVALIER SCOOTERS
K991281 · INI
Electric Mobility Corp.
Physical Medicine · 196d
Cleared Oct 27, 1999
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070 · MQG
Cook Urological, Inc.
Obstetrics & Gynecology · 131d
Cleared Oct 27, 1999
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
K992156 · LYZ
Ansell Perry
General Hospital · 124d
Cleared Oct 27, 1999
IV ADMINISTRATION SET
K992266 · FPA
New Alliance of Independent Medical...
General Hospital · 113d
Cleared Oct 27, 1999
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
K992421 · BSZ
Accutron, Inc.
Anesthesiology · 98d
Cleared Oct 27, 1999
TUBULAR ELECTRODE DEVICE
K992542 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 89d
Cleared Oct 27, 1999
ALPHA INFUSION PUMP
K992551 · MEB
Advanced Infusion, Inc.
General Hospital · 89d