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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
152977–153000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1984
PERCUTANEOUS TRIG. FINGER RELEASE KNIFE
K841320 · GES
Anapach Effort, Inc.
General & Plastic Surgery · 22d
Cleared Apr 24, 1984
MINOR SURGICAL LIGHT MODEL 180
K841360 · FTD
American Sterilizer Co.
General & Plastic Surgery · 22d
Cleared Apr 24, 1984
MISTY OX DISPOS. NEBULIZER
K841469 · CCQ
Medical Molding Corp. of America
Anesthesiology · 15d
Cleared Apr 24, 1984
FRASER HARLAKE HOPE III RESUSCITATOR
K841496 · BTM
Fraser Harlake, Inc.
Anesthesiology · 14d
Cleared Apr 23, 1984
SHARPLAN #745 LASER SURG. UNIT
K832551
Laser Industries , Ltd.
General & Plastic Surgery · 266d
Cleared Apr 23, 1984
ELMED WMC 10 AND BC 50 M/M
K832589
Elmed, Inc.
Ophthalmic · 265d
Cleared Apr 23, 1984
AAP DOSIMETRY RELEASE OR BASIN SETS
K832826 · FNY
American Hospital Supply Corp.
General Hospital · 248d
Cleared Apr 23, 1984
DERMOLAS
K832983 · GEX
Meditec, Inc.
General & Plastic Surgery · 234d
Cleared Apr 23, 1984
NEUROLOGICAL SPONGE ON PLASTIC STICK
K833734
American Medical Disposable, Inc.
Neurology · 181d
Cleared Apr 23, 1984
AN ODOR ABSORBENT BANDAGE
K833735 · NAB
American Medical Disposable, Inc.
General & Plastic Surgery · 181d
Cleared Apr 23, 1984
ADHESIVE TRACTION TAPE
K834142 · GAD
Devon Industries, Inc.
General & Plastic Surgery · 144d
Cleared Apr 23, 1984
ULTRA IMAGER 2000
K834282 · IYO
Honeywell, Inc.
Radiology · 154d
Cleared Apr 23, 1984
FIXATION STAPLES
K834513
Stryker Corp.
General & Plastic Surgery · 124d
Cleared Apr 23, 1984
FIXATION STAPLE KIT - DLIDE HAMMER
K834515 · HXJ
Stryker Corp.
Orthopedic · 124d
Cleared Apr 23, 1984
EPITRON SUPER
K834572 · KCW
Leo Unlimited, Inc.
General & Plastic Surgery · 116d
Cleared Apr 23, 1984
SILGMANN SOLARIUM S-TYPE 1218 COMBO
K840137 · FTC
Tannhut
General & Plastic Surgery · 104d
Cleared Apr 23, 1984
REPTILASE-R HA35
K840210 · JCO
Wellcome Diagnostics
Hematology · 95d
Cleared Apr 23, 1984
DISPOSABLE, PRESSURE RELIEF VALVE
K840276
Hospitak, Inc.
Physical Medicine · 91d
Cleared Apr 23, 1984
DIACELIN
K840288 · GGN
Diatech, Inc.
Hematology · 90d
Cleared Apr 23, 1984
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · DWS
Imm Enterprises , Ltd.
Cardiovascular · 90d
Cleared Apr 23, 1984
CAT. 14-CLINICAL TOXIOLOGY DEVICES
K840318 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 90d
Cleared Apr 23, 1984
PACEMAKER PULSE GENERATOR W/ELECTRODE
K840353 · DRO
Ross Research, Inc.
Cardiovascular · 88d
Cleared Apr 23, 1984
SURG A STAT FINE TIP 5
K840493
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 77d
Cleared Apr 23, 1984
CRYO SURG 5900
K840536 · GEH
Frigitronics of Connecticut, Inc.
General & Plastic Surgery · 75d