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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121993–122016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1991
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
K910255 · JIW
Sigma Diagnostics, Inc.
Hematology · 71d
Cleared Apr 03, 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Apr 03, 1991
GEM-PREMIER SYSTEM
K910305 · JGS
Mallinckrodt Sensor Systems, Inc.
Chemistry · 69d
Cleared Apr 03, 1991
IL PHENOBARBITAL ASSAY SYSTEM
K910355 · DLZ
Instrumentation Laboratory CO
Toxicology · 64d
Cleared Apr 03, 1991
MICROZYME TSH ENZYME IMMUNOASSAY KIT
K910411 · JLW
Immunotech Corp.
Chemistry · 64d
Cleared Apr 03, 1991
TEETHMATE-F
K910424 · EMA
Kuraray Co.
Dental · 63d
Cleared Apr 03, 1991
GLUCOSE V
K910573 · CGA
Caro Med, Inc.
Chemistry · 51d
Cleared Apr 03, 1991
MCLAUGHLIN LAPAROSCOPIC GRASPER
K910578 · HIS
Marlo Surgical Technology
Obstetrics & Gynecology · 51d
Cleared Apr 03, 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
K910589 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Apr 03, 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
K910658 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Apr 03, 1991
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
K910666 · JSP
Vitek Systems, Inc.
Microbiology · 51d
Cleared Apr 03, 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · KLS
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Apr 03, 1991
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
K910829 · LAS
Bio-Rad
Toxicology · 35d
Cleared Apr 03, 1991
TARGET(TM) CANNABINOIDS-V TEST
K910892 · LDJ
V-Tech, Inc.
Toxicology · 30d
Cleared Apr 03, 1991
TARGET(TM) CANNABINOIDS-R TEST
K910893 · LDJ
V-Tech, Inc.
Toxicology · 30d
Cleared Apr 03, 1991
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
K911056 · DIP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Apr 03, 1991
CIBA CORNING ACS CKMB IMMUNOASSAY
K911121 · JHX
Ciba Corning Diagnostics Corp.
Chemistry · 22d
Cleared Apr 03, 1991
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
K911267 · IXR
Tri W-G, Inc.
Radiology · 23d
Cleared Apr 02, 1991
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
K902227 · LIF
Serim Research Corp.
Gastroenterology & Urology · 320d
Cleared Apr 02, 1991
CONDOR ANALOG INFLATION SYRINGE
K904508 · MAV
Professional Medical Services
Cardiovascular · 180d
Cleared Apr 02, 1991
BIVONA ENDOTRACHEAL TUBE STYLET
K905052 · BSR
Bivona Medical Technologies
Anesthesiology · 145d
Cleared Apr 02, 1991
OCHSNER 500 VASCULAR PROSTHESIS
K905269 · DSY
Intervascular, Inc.
Cardiovascular · 130d
Cleared Apr 02, 1991
AUTOGENESIS(TM) AUTOMATOR
K905514 · KTT
Advanced Biosearch Assn.
Orthopedic · 116d
Cleared Apr 02, 1991
CANNULA INTRODUCTION SET
K910015 · HET
Lazarus Medical, Inc.
Obstetrics & Gynecology · 90d