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
93121–93144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1997
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
K972004 · CGZ
Alko Diagnostic Corp.
Chemistry · 17d
Cleared Jun 13, 1997
NYLON COATED SPECULA
K925501 · HIB
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 1687d
Cleared Jun 13, 1997
MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
K961779 · BZH
Avion Medical Products, Inc.
Anesthesiology · 401d
Cleared Jun 13, 1997
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787 · KGI
Hologic, Inc.
Radiology · 400d
Cleared Jun 13, 1997
LXN FRUCTOSAMINE TEST SYSTEM
K962597 · LCP
Lxn Corp.
Chemistry · 346d
Cleared Jun 13, 1997
DEVILBISS 8650D
K963349 · BTI
Devilbiss Health Care, Inc.
Anesthesiology · 291d
Cleared Jun 13, 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
K963575 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 280d
Cleared Jun 13, 1997
MITAYA ALUMINUM INTERSPACED X-RAY GRID
K964025 · IXJ
X-Ray Accessory Corp.
Radiology · 249d
Cleared Jun 13, 1997
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K964507 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 217d
Cleared Jun 13, 1997
VERIDOSE DIODES
K964785 · IYE
Victoreen, Inc.
Radiology · 196d
Cleared Jun 13, 1997
PEAK FLOW METER
K970507 · BZH
Intl. Medical, Inc.
Anesthesiology · 123d
Cleared Jun 13, 1997
N/A
K970590 · ILY
North American Technical Services Corp.
Physical Medicine · 115d
Cleared Jun 13, 1997
N/A
K970592 · ILY
North American Technical Services Corp.
Physical Medicine · 115d
Cleared Jun 13, 1997
SIMS HYPERINFLATION BAG SYSTEM
K970785 · NHK
Sims
Anesthesiology · 101d
Cleared Jun 13, 1997
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K970959 · BTM
Instrumentation Industries, Inc.
Anesthesiology · 88d
Cleared Jun 13, 1997
MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
K970964 · LLZ
International Imaging Electronics
Radiology · 88d
Cleared Jun 13, 1997
CARDIOMATCH
K970970 · KPS
Focus Medical SA
Radiology · 88d
Cleared Jun 13, 1997
PERITONEAL/CARDIAC CATHETER
K970983 · JXG
Integra Neurocare, LLC
Neurology · 87d
Cleared Jun 13, 1997
AUTIMO
K971001 · IXI
Medizintechnik, GmbH
Radiology · 86d
Cleared Jun 13, 1997
OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
K971054 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 81d
Cleared Jun 13, 1997
THERAPAX SXT 150
K971074 · JAD
Pantak, Inc.
Radiology · 81d
Cleared Jun 13, 1997
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
K971087 · HQY
W.J. Byrnes & Co. of Los Angeles, Inc.
Ophthalmic · 80d
Cleared Jun 13, 1997
GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE
K971115 · ITX
Protek Medical Products, Inc.
Radiology · 78d
Cleared Jun 13, 1997
DUALINE 400 CIC
K971158 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 77d