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
82249–82272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 2000
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
K001039 · LPH
Implex Corp.
Orthopedic · 76d
Cleared Jun 15, 2000
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
K001082 · FYD
Stackhouse, Inc.
General Hospital · 72d
Cleared Jun 15, 2000
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
K001084 · LXT
Immedica, Inc.
Orthopedic · 72d
Cleared Jun 15, 2000
PIPET CURET
K001545 · HHK
Milex Products, Inc.
Obstetrics & Gynecology · 28d
Cleared Jun 15, 2000
MACH 7
K990060 · KOJ
Kreativ, Inc.
Dental · 524d
Cleared Jun 15, 2000
STERRAD 100S STERILIZER
K991999 · MLR
Advanced Sterilization Products
General Hospital · 367d
Cleared Jun 14, 2000
AC POWERED THERMAL CAUTERY UNIT
K000893 · HQO
Starion Instruments
Ophthalmic · 86d
Cleared Jun 14, 2000
NBS CONNECTING TUBE SET
K001068 · HIF
Nbs Products CO
Obstetrics & Gynecology · 72d
Cleared Jun 14, 2000
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
K001112 · DXJ
General Electric Medical Systems...
Cardiovascular · 69d
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