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
70969–70992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2003
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY
K032638 · LLZ
Planar Systems, Inc.
Radiology · 15d
Cleared Sep 11, 2003
FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
K032640 · IYO
U-Systems, Inc.
Radiology · 15d
Cleared Sep 11, 2003
MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER
K032658 · FLL
Microlife Intellectual Property GmbH
General Hospital · 14d
Cleared Sep 10, 2003
PATHWAY ACCESS SHEATH CATHETER
K030734 · DYB
Vertelink Corporation
Cardiovascular · 184d
Cleared Sep 10, 2003
OSTEOMED ALVEOLAR DISTRACTION SYSTEM
K030790 · MQN
Osteomed LP
Dental · 182d
Cleared Sep 10, 2003
STERI-DRAPE SURGICAL DRAPES
K031287 · KKX
3M Company
General Hospital · 140d
Cleared Sep 10, 2003
BINDAZYME CLQ CIC EIA KIT
K031563 · DAK
The Binding Site, Ltd.
Immunology · 114d
Cleared Sep 10, 2003
UNIVERSAL NEURO SYSTEM
K031659 · JEY
Stryker Instruments
Dental · 105d
Cleared Sep 10, 2003
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW...
K031800 · FTC
Solarc Systems, Inc.
General & Plastic Surgery · 91d
Cleared Sep 10, 2003
INTERA-SENSATION FAMILY
K031815 · LNH
Philips Medical Systems
Radiology · 90d
Cleared Sep 10, 2003
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
K032134 · JZO
Kronus Market Development Associates,...
Immunology · 61d
Cleared Sep 10, 2003
WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
K032271 · GEH
Wartner USA B.V.
General & Plastic Surgery · 49d
Cleared Sep 10, 2003
SIREMOBIL ISO-C 3D
K032280 · IZL
Siemens AG
Radiology · 48d
Cleared Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399 · LON
bioMerieux, Inc.
Microbiology · 37d
Cleared Sep 10, 2003
SELDINGER SAFETY NEEDLE INTRODUCER
K032404 · DYB
Hdc Corp.
Cardiovascular · 37d
Cleared Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · DHR
Roche Diagnostics Corp.
Immunology · 23d
Cleared Sep 10, 2003
IP-XS COMPRESSION NAIL SYSTEM
K032548 · HSB
Plus Orthopedics
Orthopedic · 23d
Cleared Sep 10, 2003
MICRUS MICROCATHETER
K032624 · DQO
Micrus Corp.
Cardiovascular · 15d
Cleared Sep 09, 2003
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09,...
K022752 · CAZ
Hdc Corp.
Anesthesiology · 386d
Cleared Sep 09, 2003
ARABELLA NCPAP MASKS
K030563 · BZD
Hamilton Medical AG
Anesthesiology · 200d
Cleared Sep 09, 2003
AXIOM BIOLASER LLLT SERIES-1
K030622 · NHN
Axiom Usa., Inc.
Physical Medicine · 194d
Cleared Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701 · MSV
Immco Diagnostics, Inc.
Immunology · 187d
Cleared Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
K030702 · MSV
Immco Diagnostics, Inc.
Immunology · 187d
Cleared Sep 09, 2003
BLU-U, MODEL 4170
K031805 · GEX
Dusa Pharmaceuticals, Inc.
General & Plastic Surgery · 90d