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
77449–77472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206 · DFC
Roche Diagnostics Corp.
Chemistry · 52d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
K013249 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 16, 2001
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
K013274 · NEW
Cp Medical
General & Plastic Surgery · 46d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013440 · MNI
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
ISOLA POLYAXIAL WASHER
K013441 · KWP
Depuyacromed
Orthopedic · 30d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013444 · MNH
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
LONG LENGTH DYAX NAIL
K013468 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Nov 16, 2001
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K013480 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 28d
Cleared Nov 16, 2001
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
K013499 · GEX
Diomed, Inc.
General & Plastic Surgery · 25d
Cleared Nov 16, 2001
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 25d
Cleared Nov 16, 2001
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
K013557 · MBI
Walter Lorenz Surgical, Inc.
Orthopedic · 23d
Cleared Nov 16, 2001
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
K013627 · IYN
Medison America, Inc.
Radiology · 11d
Cleared Nov 16, 2001
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K013709 · FET
Hill-Rom, Inc.
Gastroenterology & Urology · 8d
Cleared Nov 15, 2001
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · LCP
Dade Behring, Inc.
Chemistry · 156d
Cleared Nov 15, 2001
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY...
K012544 · JCT
Vascular Architects, Inc.
General & Plastic Surgery · 100d
Cleared Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 91d
Cleared Nov 15, 2001
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · DRT
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
K013278 · DEL
Roche Diagnostics Corp.
Chemistry · 45d
Cleared Nov 15, 2001
PASS SPINAL SYSTEM
K013431 · MNI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 15, 2001
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
K013463 · GEI
Arthrocare Corp.
General & Plastic Surgery · 28d
Cleared Nov 15, 2001
CAPIOX RX HARDSHELL RESERVOIR
K013526 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 23d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
K013544 · DAP
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · DAP
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Nov 15, 2001
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · OWB
Toshiba America Medical Systems, In.C
Radiology · 15d