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
81745–81768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2000
THERMAL CAUTERY FORCEPS
K001262 · GEI
Starion Instruments
General & Plastic Surgery · 56d
Cleared Jun 14, 2000
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
K001273 · GEI
Starion Instruments
General & Plastic Surgery · 55d
Cleared Jun 14, 2000
MICROPERFORATION INSTRUMENT
K001507 · LXH
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Jun 14, 2000
MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE...
K001593 · GEI
Chester Labs, Inc.
General & Plastic Surgery · 22d
Cleared Jun 14, 2000
MALLORY HEAD MODULAR CALCAR
K001660 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Jun 14, 2000
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
K001713 · MOS
Mri Devices Corp.
Radiology · 9d
Cleared Jun 14, 2000
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
K994209 · DWF
Cobe Cardiovascular, Inc.
Cardiovascular · 183d
Cleared Jun 13, 2000
EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION
K000237 · DXN
Cybercare, Inc.
Cardiovascular · 138d
Cleared Jun 13, 2000
SCANDINAVIAN IVF SCIENCES AB, HYBASE-1
K000627 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 117d
Cleared Jun 13, 2000
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
K000981 · EJH
C-Mix
Dental · 78d
Cleared Jun 13, 2000
DIGITAL INTEGRATION SYSTEM, DIS2000
K001012 · LLZ
Wellington Medical Systems, Inc.
Radiology · 76d
Cleared Jun 13, 2000
IVC THREE BLASTOCYST MEDIUM, CAT # 2007
K001113 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 68d
Cleared Jun 13, 2000
HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
K001309 · EBG
Kay See Dental Mfg. Co.
Dental · 49d
Cleared Jun 13, 2000
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
K001326 · NCK
Ocular Concepts, LLC
Ophthalmic · 48d
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100...
K001475 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 33d
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
K001485 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 32d
Cleared Jun 13, 2000
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS...
K001584 · LPL
Medvice Consulting, Inc.
Ophthalmic · 22d
Cleared Jun 13, 2000
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR...
K001620 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 19d
Cleared Jun 13, 2000
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
K001762 · DXG
Pulsion Medical Systems, Inc.
Cardiovascular · 4d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC...
K992532 · FOZ
Baxter Healthcare Corp
General Hospital · 320d
Cleared Jun 12, 2000
DORNIER MEDILAS D SKINPULSE
K000072 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 154d
Cleared Jun 12, 2000
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
K000687 · GMQ
Beacon Biologicals, Inc.
Microbiology · 104d
Cleared Jun 12, 2000
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
K001252 · IOR
Maxhealth Corp.
Physical Medicine · 54d
Cleared Jun 12, 2000
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
K001284 · HAW
Medtronic Surgical Navigation...
Neurology · 52d