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
86833–86856 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1999
PHILIPS NICOL COLLIMATOR FAMILY
K990423 · IZW
Philips Medical Systems, Inc.
Radiology · 32d
Cleared Mar 15, 1999
MEDLINE EXCEL WHEELCHAIRS
K990463 · IOR
Medline
Physical Medicine · 31d
Cleared Mar 15, 1999
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
K990598 · KWS
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Mar 15, 1999
TETRAFILCON A
K990606 · LPL
CooperVision, Inc.
Ophthalmic · 20d
Cleared Mar 15, 1999
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER...
K990765 · OCY
Flexmedics
Gastroenterology & Urology · 7d
Cleared Mar 15, 1999
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER
K990805 · QEZ
Cordis Corp.
Cardiovascular · 4d
Cleared Mar 12, 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
K980964 · HIS
Ls Rubber Sdn Bhd
Obstetrics & Gynecology · 361d
Cleared Mar 12, 1999
IMMULITE THYROGLOBULIN MODEL LKTY
K982466 · MSW
Diagnostic Products Corp.
Immunology · 240d
Cleared Mar 12, 1999
IMMULITE 2000 THYROGLOBULIN MODEL L2KTY
K982468 · MSW
Diagnostic Products Corp.
Immunology · 240d
Cleared Mar 12, 1999
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
K982600 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 228d
Cleared Mar 12, 1999
GYNEX ELECTRODES
K982739 · HGI
Gynex Corp.
Obstetrics & Gynecology · 218d
Cleared Mar 12, 1999
SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR
K983355 · FLL
Sabratek Corp.
General Hospital · 170d
Cleared Mar 12, 1999
BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B
K983843 · MAI
Arthrex, Inc.
Orthopedic · 133d
Cleared Mar 12, 1999
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
K983918 · IXA
Mastek, Inc.
Radiology · 128d
Cleared Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC...
K984289 · LTJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 101d
Cleared Mar 12, 1999
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
K984518 · ESD
Sonic Innovations, Inc.
Ear, Nose, Throat · 81d
Cleared Mar 12, 1999
BIOSACA SYSTEM
K984580 · OLV
Biosys AB (Publ)
Neurology · 79d
Cleared Mar 12, 1999
3D-ANGIO
K984634 · JAK
Siemens Medical Corp.
Radiology · 72d
Cleared Mar 12, 1999
CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000...
K990049 · MUH
Digident , Ltd.
Radiology · 64d
Cleared Mar 12, 1999
BIOPSY-DIGIT
K990192 · IZH
Sitco, Inc.
Radiology · 50d
Cleared Mar 12, 1999
SYNERGY CEMENTED HIP STEM
K990369 · JDI
Smith & Nephew, Inc.
Orthopedic · 32d
Cleared Mar 12, 1999
ULTRACISION HARMONIC SCALPEL HAND PIECE
K990430 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 29d
Cleared Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
K990531 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Mar 11, 1999
BUZBEE
K982173 · GZJ
Mwr Electronics Industrial Co.
Neurology · 265d