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
76945–76968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 14, 2001
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
K011536 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 180d
Cleared Nov 14, 2001
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
K012738 · GEY
Depuyacromed
General & Plastic Surgery · 90d
Cleared Nov 14, 2001
CONVERGE ACETABULAR SYSTEM
K012739 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
ICE BATON
K012746 · LKX
Behive, Ltd.
Gastroenterology & Urology · 90d
Cleared Nov 14, 2001
ADC PEDIATRIC
K012750 · MQB
Agfa Corp.
Radiology · 90d
Cleared Nov 14, 2001
HEALOS BONE GRAFT MATERIAL
K012751 · MQV
Orquest, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
K012771 · GCJ
Pajunk GmbH
General & Plastic Surgery · 89d
Cleared Nov 14, 2001
N2000 BASE STATION, N2001 NURSE STATION
K012801 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 85d
Cleared Nov 14, 2001
CAROTID GUIDING SHEATH
K012812 · DYB
Terumo Medical Corp.
Cardiovascular · 84d