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
92737–92760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1997
VIDEO EYE TRAKKER
K964646 · GWN
Micromedical Technologies, Inc.
Neurology · 237d
Cleared Jul 15, 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
K965068 · LNH
Toshiba America Medical Systems, In.C
Radiology · 209d
Cleared Jul 15, 1997
UNIJECT SURGICAL GLOVES
K970160 · KGO
Uniject Gloves , Ltd.
General Hospital · 180d
Cleared Jul 15, 1997
CONFOCAL MICROSCOPE
K970414 · HJO
Con-S , Ltd.
Ophthalmic · 173d
Cleared Jul 15, 1997
ZENTIH FLOWABLE COMPOSITE (MULTIPLE)
K970683 · EBF
Foremost Dental Mfg., Inc.
Dental · 141d
Cleared Jul 15, 1997
SMILE WITH CONFIDENCE
K971002 · EHS
Lloyd V. Ziemendorf
Dental · 118d
Cleared Jul 15, 1997
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168 · MEB
Baxter Healthcare Corp
General Hospital · 106d
Cleared Jul 15, 1997
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
K971355 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 95d
Cleared Jul 15, 1997
LL BI-FOCAL, DAILY WEAR CONTACT LENS
K971647 · LPL
Lombart Lenses, Ltd.
Ophthalmic · 71d
Cleared Jul 15, 1997
BIVALVE NASAL SPLINT
K972096 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 41d
Cleared Jul 14, 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
K951459 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 837d
Cleared Jul 14, 1997
COBE CENTURY PERFUSION PUMP
K960974 · DWB
Cobe Cardiovascular, Inc.
Cardiovascular · 490d
Cleared Jul 14, 1997
GANTEX MODEL NSG-75PF
K962539 · KGO
American Pro Latex, Inc.
General Hospital · 381d
Cleared Jul 14, 1997
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K963208 · JXE
Neurotron Medical
Neurology · 332d
Cleared Jul 14, 1997
MRI NEEDLES
K963565 · FCG
Cook, Inc.
Gastroenterology & Urology · 312d
Cleared Jul 14, 1997
DTX-100 BONE DENSITOMETER
K963789 · KGI
Osteometer Meditech A/S
Radiology · 297d
Cleared Jul 14, 1997
N-ASSAY TIA C4 TEST KIT
K964297 · DBI
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964298 · CZW
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964299 · LKL
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964300 · DBI
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964301 · DAD
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA C1-INACTIVATOR TEST KIT
K965024 · DBA
Crestat Diagnostics, Inc.
Immunology · 209d
Cleared Jul 14, 1997
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
K965100 · DEM
Crestat Diagnostics, Inc.
Immunology · 206d
Cleared Jul 14, 1997
CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER
K965128 · GEX
Cynosure, Inc.
General & Plastic Surgery · 203d