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
75097–75120 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2002
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · HIB
Cypress Medical Products, Ltd.
Obstetrics & Gynecology · 52d
Cleared Jul 12, 2002
HEMADERM COTAINING HEMADEX CLOTTING BEADS
K021678 · QSY
Medafor, Inc.
General & Plastic Surgery · 52d
Cleared Jul 12, 2002
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
K021697 · JJX
Bionostics, Inc.
Chemistry · 51d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874 · DXG
Abbott Laboratories
Cardiovascular · 35d
Cleared Jul 12, 2002
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
K021927 · LXG
Biomet, Inc.
Hematology · 30d
Cleared Jul 12, 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND...
K021970 · LPH
Implex Corp.
Orthopedic · 25d
Cleared Jul 12, 2002
HORIZONS CYTOLOGY BRUSH
K021998 · FDX
Horizons Intl. Corp.
Gastroenterology & Urology · 23d
Cleared Jul 12, 2002
MPOWER, MODEL 712 SERIES
K022001 · KPS
Positron Corp.
Radiology · 23d
Cleared Jul 12, 2002
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
K022053 · JHO
Sebia
Chemistry · 18d
Cleared Jul 12, 2002
EIZO, MODEL FC-2091
K022109 · LLZ
Eizo Nanao Corporation
Radiology · 14d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · JEC
Smith & Nephew, Inc.
Orthopedic · 364d
Cleared Jul 11, 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
K013873 · GEI
Boston Scientific Corp
General & Plastic Surgery · 232d
Cleared Jul 11, 2002
LUTZ NEEDLE
K013892 · BSP
Ballard Medical Products
Anesthesiology · 230d
Cleared Jul 11, 2002
NEUROTECH MEDISTIM PLUS, TYPE 291
K014019 · IPF
Bio-Medical Research, Ltd.
Physical Medicine · 217d
Cleared Jul 11, 2002
NT MEDITENS PLUS, TYPE 290
K014020 · GZJ
Bio-Medical Research, Ltd.
Neurology · 217d
Cleared Jul 11, 2002
FT101 FOREHEAD THERMOMETER
K020433 · FLL
Idt Technology Limited
General Hospital · 153d
Cleared Jul 11, 2002
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020792 · LDP
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jul 11, 2002
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020794 · DKJ
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jul 11, 2002
NO-POKES NEEDLE SAFETY DEVICE
K020921 · FMI
Bemis Mfg. Co.
General Hospital · 112d
Cleared Jul 11, 2002
ILT TORQUER, MODEL 114TR1
K021243 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 83d
Cleared Jul 11, 2002
MONARCH SPINE SYSTEM
K021335 · MNH
Depuyacromed
Orthopedic · 76d
Cleared Jul 11, 2002
DELIGHT DENTAL ER: YAG LASER SYSTEM
K021616 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 56d
Cleared Jul 11, 2002
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950...
K021817 · GEI
Aaron Medical Industries
General & Plastic Surgery · 38d
Cleared Jul 11, 2002
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
K021882 · DCN
Good Biotech Corp.
Immunology · 34d