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
80209–80232 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2001
2010 PLUS HOLTER FOR WINDOWS
K003940 · MLO
Agilent Technologies
Cardiovascular · 49d
Cleared Feb 08, 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · ESW
Rusch Intl.
Gastroenterology & Urology · 31d
Cleared Feb 08, 2001
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
K010190 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 17d
Cleared Feb 08, 2001
PROTRACT PRESS FIT HIP STEM-HA COATED
K010241 · LPH
Stelkast Company
Orthopedic · 14d
Cleared Feb 07, 2001
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
K000776 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 334d
Cleared Feb 07, 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 180d
Cleared Feb 07, 2001
HOLY DRAGON ACUPUNCTURE NEEDLES
K002910 · MQX
Anc Import & Export Co. , Ltd.
General Hospital · 142d
Cleared Feb 07, 2001
ULTRASOUND SCANNER TYPE 2101
K003041 · IYO
B & K Medical A/S
Radiology · 131d
Cleared Feb 07, 2001
BIO-EYE II ORBITAL IMPLANT
K003338 · HPZ
Integrated Orbital Implants, Inc.
Ophthalmic · 105d
Cleared Feb 07, 2001
ANCURE LLIAC BALLOON CATHETER
K003495 · DQY
Guidant Cardiac and Vascular Surgery
Cardiovascular · 86d
Cleared Feb 07, 2001
CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
K003533 · JOJ
Steritec Products, Inc.
General Hospital · 83d
Cleared Feb 07, 2001
ADAPTERS WITH X-COATING
K003604 · DTL
Terumo Cardiovascular Systems Corp.
Cardiovascular · 78d
Cleared Feb 07, 2001
THERMOFX MESH
K003757 · JEY
Bionx Implants, Ltd.
Dental · 63d
Cleared Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
K010064 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 07, 2001
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
K010130 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 22d
Cleared Feb 06, 2001
EXCITE DSC
K003293 · KLE
Ivoclar North America, Inc.
Dental · 109d
Cleared Feb 06, 2001
PALMLIGHT
K003383 · EBZ
Ultradent Products, Inc.
Dental · 98d
Cleared Feb 06, 2001
TAI-CHI ACUPUNCTURE NEEDLES
K003760 · MQX
Lhasa Medical, Inc.
General Hospital · 62d
Cleared Feb 06, 2001
COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
K003958 · FZP
Coalescent Surgical
General & Plastic Surgery · 47d
Cleared Feb 06, 2001
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT...
K004048 · LYY
Tillotson Healthcare Corp.
General Hospital · 39d
Cleared Feb 06, 2001
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+,...
K010238 · FLL
Actherm, Inc.
General Hospital · 12d
Cleared Feb 06, 2001
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
K010247 · LZA
Shanghai China Star Corp
General Hospital · 11d
Cleared Feb 05, 2001
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K001781 · OLX
Neurosoft, Inc.
Neurology · 237d