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

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175,820 results
37225–37248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 2014
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH
K141840 · MBH
Zimmer, Inc.
Orthopedic · 57d
Cleared Sep 02, 2014
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
K140690 · CDQ
Shenzhen Mindray Bio-Medical...
Chemistry · 167d
Cleared Sep 02, 2014
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
K140874 · DXQ
Shanghai Goahui Rubber and Plastic...
Cardiovascular · 151d
Cleared Sep 02, 2014
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
K141078 · KTT
Orthofix Srl
Orthopedic · 130d
Cleared Sep 02, 2014
RENOVIS CEMENTED HIP SYSTEM
K141370 · JDI
Renovis Surgical Technologies, Inc.
Orthopedic · 98d
Cleared Aug 29, 2014
EIA SMDP IMMUNOASSAY
K132631 · LKP
Phadia US, Inc.
Immunology · 372d
Cleared Aug 29, 2014
HEARTWAY POWER MOBILITY SCOOTER
K132855 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 351d
Cleared Aug 29, 2014
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
K132943 · DRC
Synaptic Medical Limited
Cardiovascular · 344d
Cleared Aug 29, 2014
ACCU-CHEK Performa Blood Glucose Monitoring System
K133741 · NBW
Roche Diagnostics
Chemistry · 263d
Cleared Aug 29, 2014
SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM
K140009 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 239d
Cleared Aug 29, 2014
QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
K140342 · KGI
Mindways Software, Inc.
Radiology · 199d
Cleared Aug 29, 2014
CIVA SHEET PD-103
K140490 · KXK
Civatech Oncology, Inc.
Radiology · 183d
Cleared Aug 29, 2014
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
K140735 · MBH
Microport Orthopedics, Inc.
Orthopedic · 158d
Cleared Aug 29, 2014
CLIMB MAMMOGRAPHY VIEWER SOFTWARE
K141364 · LLZ
Climb Medical Systems, Inc.
Radiology · 98d
Cleared Aug 29, 2014
DICOMPACS DX-R WITH FLAT PANEL
K141440 · MQB
Oehm Und Rehbein GmbH
Radiology · 88d
Cleared Aug 29, 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · HRS
Synthes USA Products, LLC
Orthopedic · 57d
Cleared Aug 29, 2014
IOGYN SYSTEM
K141848 · PGT
Iogyn, Inc.
Obstetrics & Gynecology · 51d
Cleared Aug 29, 2014
SELEC-3 I.V.ADMINISTRATION SET
K142097 · FPA
Biomedix, Inc.
General Hospital · 28d
Cleared Aug 29, 2014
MEMO 3D ReChord
K142221 · KRH
Sorin Group Italia S.R.L.
Cardiovascular · 17d
Cleared Aug 28, 2014
EASYSTIM TN28_OTC
K140168 · NUH
Easymed Instruments Co., Ltd.
Neurology · 217d
Cleared Aug 28, 2014
JWX-2
K140204 · ITI
Yamaha Motor Co., Ltd.
Physical Medicine · 213d
Cleared Aug 28, 2014
FINGERTIP PULSE OXIMETER
K140582 · DQA
Shenzhen Jumper Medical Equipment...
Anesthesiology · 175d
Cleared Aug 28, 2014
DISTAL ELBOW PLATING SYSTEM
K140892 · HRS
Skeletal Dynamics, LLC
Orthopedic · 142d
Cleared Aug 28, 2014
INFRONT LUMBAR INTERBODY FUSION SYSTEM
K141443 · MAX
Infront Medical, LLC
Orthopedic · 87d