Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
47617–47640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2011
PERIOPATCH
K110750 · OLR
Mis Implants Technologies , Ltd.
General & Plastic Surgery · 42d
Cleared Apr 28, 2011
BIOMARC FIDUCIAL MARKER
K110772 · IYE
Carbon Medical Technologies, Inc.
Radiology · 38d
Cleared Apr 28, 2011
RENAISSANCE SYSTEM
K110911 · HAW
Mazor Robotics , Ltd.
Radiology · 28d
Cleared Apr 27, 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES
K102151 · LYZ
Hebei Tengda Plastic Co., Ltd.
General Hospital · 271d
Cleared Apr 27, 2011
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
K102517 · EFB
Thunder Tiger Corp.
Dental · 237d
Cleared Apr 27, 2011
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
K103204 · FTC
Solarc Systems, Inc.
General & Plastic Surgery · 177d
Cleared Apr 27, 2011
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
K103557 · DCK
Diazyme Laboratories
Chemistry · 146d
Cleared Apr 27, 2011
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K103599 · MQB
Meridian Medical Systems, LLC
Radiology · 140d
Cleared Apr 27, 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800...
K103842 · CGA
Beckman Coulter, Inc.
Chemistry · 118d
Cleared Apr 27, 2011
LIGHTY DD INFUSION SET
K110282 · FPA
Medx-Set, Ltd.
General Hospital · 86d
Cleared Apr 27, 2011
SENSITITRE AIM (TM)
K110331 · LIE
Trek Diagnostic Systems, Ltd.
Microbiology · 83d
Cleared Apr 27, 2011
TRIPLEX ER. YAG / ND: YAG SYSTEM
K110502 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 64d
Cleared Apr 27, 2011
FILMARRAY RP PANEL
K110764 · OCC
Idaho Technology, Inc.
Microbiology · 40d
Cleared Apr 27, 2011
IMPELLA CONTROLLER WITH FLOW CONTROL
K110845 · KFM
Abiomed, Inc.
Cardiovascular · 30d
Cleared Apr 27, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K110865 · KWS
Tornier, Inc.
Orthopedic · 29d
Cleared Apr 27, 2011
CUBESCAN / BIOCON-700
K111021 · ITX
Mcube Technology Co., Ltd.
Radiology · 15d
Cleared Apr 26, 2011
NOVAKONE SPHERICAL AND TORIC LENSES
K102557 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 231d
Cleared Apr 26, 2011
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
K103363 · MXJ
Zeus Scientific, Inc.
Microbiology · 160d
Cleared Apr 26, 2011
DISPOSABLE INSULIN SYRINGE
K110421 · FMF
Wenzhou Wuzhou Import & Export Co., Ltd.
General Hospital · 71d
Cleared Apr 26, 2011
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
K110834 · LLZ
Ge Healthcare
Radiology · 32d
Cleared Apr 26, 2011
PRESTODR 4143
K110849 · KPR
Cmt Medical Technologies, Ltd.
Radiology · 29d
Cleared Apr 26, 2011
VAPRO PLUS INTERMITTENT CATHETER
K110862 · GBM
Hollister Incorporated
Gastroenterology & Urology · 28d
Cleared Apr 26, 2011
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K110999 · ITX
Edan Instruments, Inc.
Radiology · 15d
Cleared Apr 25, 2011
INVADER MTHFR 1298
K100496 · OMM
Hologic, Inc.
Pathology · 427d