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
76081–76104 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2002
VT-1
K020154 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 77d
Cleared Apr 04, 2002
SUPPORT SLEEVE
K020258 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 69d
Cleared Apr 04, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020323 · LON
Becton, Dickinson & CO
Microbiology · 79d
Cleared Apr 04, 2002
CAL-CHEX CD PLUS
K020469 · KRX
Streck Laboratories, Inc.
Hematology · 51d
Cleared Apr 04, 2002
LONG LENGTH GAMMA NAIL
K020773 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 04, 2002
GE VIVID 3 EXPERT
K020789 · IYN
General Electric Co.
Radiology · 24d
Cleared Apr 04, 2002
GARAVENTA SUPER-TRAC TRE-52
K020933 · ING
Garaventa Accessibility
Physical Medicine · 13d
Cleared Apr 04, 2002
ADPER PROMPT
K020946 · KLE
3M Espe AG Dental Products
Dental · 10d
Cleared Apr 04, 2002
APOLLO, MODEL 1124525
K020949 · EJT
Sterngold
Dental · 10d
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