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
93649–93672 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 13, 1997
AMO DIPLOMAX/OPSYS CONSOLE
K971186 · HQC
Allergan, Inc.
Ophthalmic · 73d
Cleared Jun 13, 1997
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT
K971230 · KNT
Innerdyne, Inc.
Gastroenterology & Urology · 72d
Cleared Jun 13, 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · HRX
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jun 13, 1997
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET
K971274 · CAC
Fresenius AG
Anesthesiology · 67d
Cleared Jun 13, 1997
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
K971399 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 59d
Cleared Jun 13, 1997
SUNGLASSES (NON-PRESCRIPTION)
K971707 · HQY
Niko Sunglasses Corp.
Ophthalmic · 38d
Cleared Jun 13, 1997
ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER,...
K971805 · GEI
Aaron Medical Industries
General & Plastic Surgery · 29d
Cleared Jun 13, 1997
OPTIM-EYES 450
K971875 · HQY
Taylor/Fox Enterprises, LLC
Ophthalmic · 24d
Cleared Jun 11, 1997
BIO-GIDE RESORBABLE BILAYER MEMBRANE
K960724 · NPK
Geistlich-Pharma
Dental · 475d
Cleared Jun 11, 1997
ASPISAFE GASTRIC TUBE
K961711 · BSS
B.Braun Medical, Inc.
Gastroenterology & Urology · 405d
Cleared Jun 11, 1997
DURATION STABILIZED UHMWPE
K963612 · JDI
Howmedica Corp.
Orthopedic · 274d
Cleared Jun 11, 1997
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
K963653 · HGI
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 272d
Cleared Jun 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
K964842 · CZW
Beckman Instruments, Inc.
Immunology · 190d
Cleared Jun 11, 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K965173 · JWH
Howmedica Corp.
Orthopedic · 169d
Cleared Jun 11, 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177 · MID
Immco Diagnostics, Inc.
Immunology · 145d