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
74857–74880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 13, 2002
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
K021656 · KPS
Nuclear Diagnostics
Radiology · 24d
Cleared Jun 13, 2002
RS2MI MUSCLE STIMULATOR FAMILY
K021763 · IPF
Rs Medical
Physical Medicine · 15d
Cleared Jun 12, 2002
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
K012701 · JOZ
Accumetrics, Inc.
Hematology · 302d
Cleared Jun 12, 2002
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
K012969 · LTZ
Medtech Products , Ltd.
Obstetrics & Gynecology · 281d
Cleared Jun 12, 2002
AFB (ABSORBABLE FOAM BUTTRESS)
K014183 · FTL
J&J Corporate Biomaterials Center
General & Plastic Surgery · 174d
Cleared Jun 12, 2002
ACUSTIM
K014273 · BWK
S.H.P. Intl. Pty., Ltd.
Neurology · 167d
Cleared Jun 12, 2002
K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
K020827 · NUC
Personal Products Co., Div. of Mcneil...
Obstetrics & Gynecology · 90d
Cleared Jun 12, 2002
BD INTROSYTE PRECISION INTRODUCER
K020834 · DYB
Becton Dickinson Infusion Therapy...
Cardiovascular · 90d
Cleared Jun 12, 2002
CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60
K020835 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d