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
80713–80736 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2000
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
K002691 · KKX
Com-Med International, Inc.
General Hospital · 101d
Cleared Dec 08, 2000
COOL-TEC ELECTRODES
K002841 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 87d
Cleared Dec 08, 2000
PAFLUFOCON C AND E DAILY CONTACT LENS
K002845 · HQD
Paragon Vision Sciences
Ophthalmic · 87d
Cleared Dec 08, 2000
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
K002868 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 86d
Cleared Dec 08, 2000
MAGELLAN VENTILATOR
K002951 · CBK
Oceanic Medical Products, Inc.
Anesthesiology · 78d
Cleared Dec 08, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
K002969 · GWF
Xltek
Neurology · 77d
Cleared Dec 08, 2000
STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
K003002 · JOJ
Steritec Products, Inc.
General Hospital · 73d
Cleared Dec 08, 2000
TISSUELINK BIPOLAR FORCEPS
K003005 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 73d
Cleared Dec 08, 2000
VASCULAR CLOSURE DEVICE
K003169 · GDW
Std Mfg., Inc.
General & Plastic Surgery · 59d
Cleared Dec 08, 2000
THERMAGE THERMACOOL II SYSTEM
K003183 · GEI
Thermage, Inc.
General & Plastic Surgery · 58d
Cleared Dec 08, 2000
OPUS ROD FIXATION SYSTEM
K003490 · MNH
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Dec 08, 2000
NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP,...
K003674 · GEI
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 9d
Cleared Dec 08, 2000
SW ULTRASOUND, MODELS 331, 311, 333
K991613 · IMI
Starbene
Physical Medicine · 578d
Cleared Dec 07, 2000
TCM400
K001866 · LPP
Radiometer Medical A/S
Anesthesiology · 170d
Cleared Dec 07, 2000
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
K002481 · LDF
Zcv ,Inc.
Cardiovascular · 115d
Cleared Dec 07, 2000
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 31d
Cleared Dec 07, 2000
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
K003450 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 07, 2000
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
K003452 · DRF
Ep Technologies, Inc.
Cardiovascular · 30d
Cleared Dec 06, 2000
DARDIK CAROTID SHUNT
K001621 · MJN
Vascutech, Inc.
Cardiovascular · 194d
Cleared Dec 06, 2000
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · DIS
OraSure Technologies, Inc.
Toxicology · 160d
Cleared Dec 06, 2000
SLEEPSTRIP DISPOSABLE APNEA SCREENER
K002135 · MNR
Influent , Ltd.
Anesthesiology · 145d
Cleared Dec 06, 2000
AEDEFIBRILLATOR
K002232 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 135d
Cleared Dec 06, 2000
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K002794 · CBF
Hypertec, Inc.
Anesthesiology · 90d
Cleared Dec 06, 2000
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
K002795 · CBF
Hypertec, Inc.
Anesthesiology · 90d