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
86305–86328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1999
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
K983385 · LCJ
Hutchison Intl., Inc.
General & Plastic Surgery · 171d
Cleared Mar 15, 1999
ITI DENTAL IMPLANT SYSTEM
K983742 · DZE
Institut Straumann AG
Dental · 143d
Cleared Mar 15, 1999
IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
K983835 · JWH
Implex Corp.
Orthopedic · 136d
Cleared Mar 15, 1999
MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO...
K983882 · HXR
Micro-Medical Devices, Inc.
General & Plastic Surgery · 133d
Cleared Mar 15, 1999
HEMOSLEEVE, MODEL 4.0MM, 5.5MM
K984018 · GEI
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 123d
Cleared Mar 15, 1999
BACK-ON-TRAC, MODEL 101BOT
K984190 · HST
Back-On-Track, Inc.
Neurology · 112d
Cleared Mar 15, 1999
EXCELSIOR PORCELAIN SYSTEM
K984427 · EIH
Ney Dental, Inc.
Dental · 94d
Cleared Mar 15, 1999
TIGRAN HIP PROSTHESIS
K984492 · LPH
Ponmed , Ltd.
Orthopedic · 88d
Cleared Mar 15, 1999
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534 · GXQ
W.L. Gore & Associates, Inc.
Neurology · 84d
Cleared Mar 15, 1999
THE BIOPLATE SHUNT CONNECTOR
K984583 · JXG
Biomedics
Neurology · 81d
Cleared Mar 15, 1999
DRG MEDIUM SCREW SYSTEM
K990019 · HWC
Dolphin Medical Technologies, Inc.
Orthopedic · 70d
Cleared Mar 15, 1999
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K990089 · GAP
Aesculap, Inc.
General & Plastic Surgery · 63d
Cleared Mar 15, 1999
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
K990152 · HSB
Howmedica Osteonics Corp.
Orthopedic · 55d
Cleared Mar 15, 1999
PLUS FRACTURE HEAD PROSTHESIS
K990309 · KWL
Plus Orthopedics
Orthopedic · 42d
Cleared Mar 15, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
K990391 · JJY
Bio-Rad
Chemistry · 34d
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