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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38545–38568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2014
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
K133176 · LPL
Ciba Vision Corporation
Ophthalmic · 104d
Cleared Jan 29, 2014
TANDEMHEART FEMORAL VENOUS CANNULA SET
K133236 · DWF
Cardiacassist, Inc.
Cardiovascular · 100d
Cleared Jan 29, 2014
CADWELL FLEX EEG/PSG
K133355 · GWQ
Cadwell Industries, Inc.
Neurology · 90d
Cleared Jan 28, 2014
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
K131330 · LJM
Gold Standard Diagnostics
Immunology · 265d
Cleared Jan 28, 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K131413 · KTT
Zimmer, Inc.
Orthopedic · 257d
Cleared Jan 28, 2014
EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM
K133541 · HRS
Emerge Medical
Orthopedic · 71d
Cleared Jan 28, 2014
OTC PATCH
K133723 · NUH
Well-Life Healthcare Limited
Neurology · 53d
Cleared Jan 27, 2014
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
K131244 · CEC
Roche Diagnostics
Chemistry · 271d
Cleared Jan 27, 2014
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
K131309 · IMI
Ibramed Equipamentos Medicos
Physical Medicine · 265d
Cleared Jan 27, 2014
ATAMA SYSTEM
K132444 · MOS
Monteris Medical,
Radiology · 174d
Cleared Jan 27, 2014
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K132638 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 157d
Cleared Jan 27, 2014
AVERSION PEDICLE SCREW SYSTEM
K133103 · MNI
K7, LLC
Orthopedic · 119d
Cleared Jan 27, 2014
4D INTEGRATED TREATMENT CONSOLE
K133331 · MUJ
Varian Medical Systems, Inc.
Radiology · 90d
Cleared Jan 27, 2014
PERI-PROSTHETIC CABLE SYSTEM
K133354 · JDQ
Biomet, Inc.
Orthopedic · 88d
Cleared Jan 27, 2014
TRITIUM STERNAL CABLE PLATE SYSTEM
K133785 · JDQ
Pioneer Surgical Technology, Inc.
Orthopedic · 46d
Cleared Jan 27, 2014
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
K133986 · MOS
Resonance Innovations, LLC
Radiology · 32d
Cleared Jan 24, 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · LCP
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Jan 24, 2014
FETAL ULTRASONIC MONITOR AND ACCESSORIES
K131457 · KNG
Shenzhen Jumper Medical Equipment...
Obstetrics & Gynecology · 249d
Cleared Jan 24, 2014
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
K131500 · HCH
Aesculap, Inc.
Neurology · 245d
Cleared Jan 24, 2014
MPP
K131910 · NUH
Marc Pro
Neurology · 212d
Cleared Jan 24, 2014
DYNATRON PELTIER THERMOSTIM PROBE
K132057 · GXY
Dynatronics Corp.
Neurology · 205d
Cleared Jan 24, 2014
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK...
K132300 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 184d
Cleared Jan 24, 2014
EPAD
K132616 · GWF
Safeop Surgical, Inc.
Neurology · 156d
Cleared Jan 24, 2014
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
K132782 · DQK
Biosense Webster, Inc.
Cardiovascular · 140d