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
75577–75600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2002
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
K020970 · JDI
Biomet, Inc.
Orthopedic · 9d
Cleared Apr 04, 2002
PAIN CARE 4200
K020988 · MEB
Breg, Inc.
General Hospital · 8d
Cleared Apr 04, 2002
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K020997 · DTZ
Dideco S.P.A.
Cardiovascular · 7d
Cleared Apr 04, 2002
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 7d
Cleared Apr 03, 2002
SAFE-STEER GUIDE WIRE SYSTEM
K011986 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 281d
Cleared Apr 03, 2002
SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K012221 · JKA
Biosafe Laboratories, Inc.
Chemistry · 261d
Cleared Apr 03, 2002
2 PIECE MODULAR HIP STEM
K013106 · LZO
Howmedica Osteonics Corp.
Orthopedic · 198d
Cleared Apr 03, 2002
AQUIFY LENS COMFORT DROPS
K013204 · MRC
Ciba Vision Corporation
Ophthalmic · 190d
Cleared Apr 03, 2002
RIGID GAS PERMEABLE CONTACT LENS
K013762 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 141d
Cleared Apr 03, 2002
CARIS MINITOME BIOPSY INSTRUMENT
K020024 · KNW
Artemis Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 03, 2002
MFCD 118I
K020059 · LLZ
Barco N.V.
Radiology · 85d
Cleared Apr 03, 2002
IMAGEDESK
K020061 · LLZ
Barco N.V.
Radiology · 85d
Cleared Apr 03, 2002
MODIFICATION TO TRELEX MESH SURGICAL MESH
K020110 · OTN
Boston Scientific
Gastroenterology & Urology · 82d
Cleared Apr 03, 2002
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
K020147 · FMF
Medtronic Perfusion Systems
General Hospital · 77d
Cleared Apr 03, 2002
REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S...
K020308 · KGO
Ssl America'S, Inc.
General Hospital · 64d
Cleared Apr 03, 2002
UPLINK TEST SYSTEM
K020371 · DJG
OraSure Technologies, Inc.
Toxicology · 58d
Cleared Apr 03, 2002
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 51d
Cleared Apr 03, 2002
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
K020592 · DWL
Alba-Waldensian, Inc.
General Hospital · 40d
Cleared Apr 03, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
K020674 · MNH
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared Apr 03, 2002
EBI OMEGA21 SPINAL FIXATION SYSTEM
K020681 · MNH
Ebi, L.P.
Orthopedic · 30d
Cleared Apr 03, 2002
HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
K020688 · HRX
Hydrocision, Inc.
Orthopedic · 30d
Cleared Apr 03, 2002
POWER TEK II
K020761 · HRX
Biomet, Inc.
Orthopedic · 27d
Cleared Apr 03, 2002
ADVANTA SST BIFURCATED GRAFT
K020767 · DSY
Atrium Medical Corp.
Cardiovascular · 26d
Cleared Apr 03, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · DLJ
Lin-Zhi International, Inc.
Toxicology · 27d