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
73585–73608 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2002
SMARTSTEP SYSTEM
K023161 · IRN
Andante Medical Device, Ltd.
Physical Medicine · 78d
Cleared Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K023320 · DQY
Guidant Corp.
Cardiovascular · 67d
Cleared Dec 10, 2002
BIOPORTA G
K023391 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 62d
Cleared Dec 10, 2002
VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062
K023469 · FPA
Victus, Inc.
General Hospital · 55d
Cleared Dec 10, 2002
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K023732 · LPL
Ciba Vision Corporation
Ophthalmic · 34d
Cleared Dec 10, 2002
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
K023786 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Dec 10, 2002
MODIFICATION TO VIABAHN ENDOPROSTHESIS
K023811 · JCT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 25d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
K023875 · CIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K023876 · JIX
Ortho-Clinical Diagnostics, Inc.
Toxicology · 19d
Cleared Dec 09, 2002
AAP CANNULATED SCREWS
K021233 · HWC
Aap Implantate AG
Orthopedic · 235d
Cleared Dec 09, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021798 · HAW
Smith & Nephew, Inc.
Neurology · 192d
Cleared Dec 09, 2002
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH...
K022313 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 145d
Cleared Dec 09, 2002
INSTANT-VIEW TCA URINE TEST
K022693 · MLK
Alfa Scientific Designs, Inc.
Toxicology · 118d
Cleared Dec 09, 2002
ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT
K023098 · MEB
Mckinley Infuser
General Hospital · 82d
Cleared Dec 09, 2002
AMSINO TRACHEOSTOMY CARE TRAY
K023276 · LRO
Amsino International, Inc.
General & Plastic Surgery · 69d
Cleared Dec 09, 2002
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN,...
K023304 · JKR
Diagnostic Products Corp.
Chemistry · 67d
Cleared Dec 09, 2002
FISHER DIAGNOSTICS THROMBOSCREEN 1000
K023362 · GKP
Fisher Diagnostics
Hematology · 63d
Cleared Dec 09, 2002
ACCESS TOTAL T4 ASSAY
K023369 · KLI
Beckman Coulter, Inc.
Chemistry · 62d
Cleared Dec 09, 2002
WIENER LAB AMILASA 405 AA LIQUIDA
K023549 · JFJ
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 09, 2002
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
K023550 · KNK
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 09, 2002
WIENER LAB GOT (AST) UV AA LIQUIDA
K023551 · CIT
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 06, 2002
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
K021548 · GEX
Fotona D.D.
General & Plastic Surgery · 207d
Cleared Dec 06, 2002
SPECTRUM CERVICAL SPINAL SYSTEM
K022997 · KWQ
Spinal Innovations, LLC
Orthopedic · 88d
Cleared Dec 06, 2002
BECTON DICKINSON DIABETES SOFTWARE
K023219 · NBW
Becton, Dickinson & CO
Chemistry · 71d