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
75361–75384 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2002
SOPRO LIGHT SOURCES AND ACCESSORIES
K020915 · GCJ
Sopro
General & Plastic Surgery · 85d
Cleared Jun 14, 2002
RADIUS SNARE
K021441 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 39d
Cleared Jun 14, 2002
HEMOGLOBIN A1C CONTROL
K021484 · LCP
Canterbury Scientific , Ltd.
Hematology · 37d
Cleared Jun 14, 2002
SECURE RELINE/PICKUP MATERIAL
K021586 · EBI
Imtec Corp.
Dental · 31d
Cleared Jun 14, 2002
MEDGEM
K021605 · BZL
Healthetech, Inc.
Anesthesiology · 29d
Cleared Jun 14, 2002
KARMA 800 SERIES MANUAL WHEELCHAIR
K021866 · IOR
Vestil Manufacturing Corp.
Physical Medicine · 8d
Cleared Jun 13, 2002
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
K013022 · DSY
Sulzer Carbomedics, Inc.
Cardiovascular · 279d
Cleared Jun 13, 2002
X-IMAGE DIGITAL X-RAY SYSTEM
K020588 · MUH
Escape Technology, Inc.
Radiology · 111d
Cleared Jun 13, 2002
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
K020603 · DCN
Good Biotech Corp.
Chemistry · 108d
Cleared Jun 13, 2002
ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
K020630 · IYN
Ultrasonix Medical Corporation
Radiology · 107d
Cleared Jun 13, 2002
EBV-VCA IGG ELISA TEST, MODEL EBG-100
K020706 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 101d
Cleared Jun 13, 2002
EBV-EBNA IGG ELISA KIT, MODEL EBG-100
K020707 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 101d
Cleared Jun 13, 2002
EBV V VCA IGM ELISA KIT MODEL# EBM-200
K020717 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 100d
Cleared Jun 13, 2002
DEROYAL SURGICAL, UMBILICUP
K020753 · KSR
Deroyal
Hematology · 98d
Cleared Jun 13, 2002
NUVASIVE MESH
K020853 · EZX
Nuvasive, Inc.
General & Plastic Surgery · 90d
Cleared Jun 13, 2002
SPATOUCH PHOTOEPILATION SYSTEM
K020856 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 90d
Cleared Jun 13, 2002
ORACAM
K020957 · EIA
Video Dental Concepts, Inc.
Dental · 80d
Cleared Jun 13, 2002
RPI REPLACEMENT HEATING ELEMENTS
K020966 · FMT
Replacement Parts Industries, Inc.
General Hospital · 80d
Cleared Jun 13, 2002
SYNGO MR 2002B
K020991 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Jun 13, 2002
MAMMOPATH
K021113 · MWP
Fischer Imaging Corp.
Radiology · 69d
Cleared Jun 13, 2002
PRECISET DAT PLUS
K021393 · DKB
Quantimetrix Corp.
Toxicology · 42d
Cleared Jun 13, 2002
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
K021433 · MOS
Medical Advances, Inc.
Radiology · 38d
Cleared Jun 13, 2002
MODIFICATION TO ENVOY AND VISTA BRITE TIP
K021593 · DQY
Cordis Corp.
Cardiovascular · 29d
Cleared Jun 13, 2002
GP GENERAL PURPOSE DRAINAGE CATHETER
K021632 · GBO
Uresil, L.P.
General & Plastic Surgery · 27d