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
73081–73104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281 · DIO
Roche Diagnostics Corp.
Toxicology · 66d
Cleared Dec 06, 2002
VITAL STIM
K023347 · IPF
Chattanooga Group
Physical Medicine · 60d
Cleared Dec 06, 2002
PORTA GEO TI
K023389 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 58d
Cleared Dec 06, 2002
AGC SPECIAL ALLOY
K023392 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 58d
Cleared Dec 06, 2002
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH...
K023577 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 44d
Cleared Dec 06, 2002
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON...
K023661 · JJY
Cliniqa Corporation
Chemistry · 36d
Cleared Dec 06, 2002
O.B. TAMPONS
K023789 · HEB
Mcneil-Ppc, Inc.
Obstetrics & Gynecology · 23d
Cleared Dec 06, 2002
MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY
K023846 · GEI
Rita Medical Systems
General & Plastic Surgery · 17d
Cleared Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · LTK
Tosoh Medics, Inc.
Immunology · 14d