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
35641–35664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2015
X-RAY TV SYSTEM SONIALVISION G4
K142341 · JAA
Shimadzu Corp.
Radiology · 197d
Cleared Mar 06, 2015
XP300
K143109 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 128d
Cleared Mar 06, 2015
3.0T GEM RT Open Array
K143389 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 100d
Cleared Mar 06, 2015
Patient Examination Gloves
K143419 · LYY
Hartalega NGC Sdn. Bhd.
General Hospital · 98d
Cleared Mar 06, 2015
Sirius Starmobile tiara
K143537 · IZL
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Mar 06, 2015
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV...
K150322 · NDN
Pan Medical , Ltd.
Orthopedic · 25d
Cleared Mar 05, 2015
MASTRO PLUS BALLOON IN-DEFLATION DEVICE
K140943 · MAV
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 325d
Cleared Mar 05, 2015
SURGICAL GOWN
K141467 · FYA
Xuchang Zhengde Environstar Medical...
General Hospital · 275d
Cleared CT Mar 05, 2015
Nellcor Bedside Respiratory Patient Monitoring System
K141518 · DQA
Covidien
Anesthesiology · 269d
Cleared Mar 05, 2015
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
K141655 · OBE
Inova Diagnostics, Inc.
Immunology · 258d
Cleared Mar 05, 2015
INFINITY (TM) TOTAL ANKLE SYSTEM
K141740 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 251d
Cleared Mar 05, 2015
WATERLASE IPLUS S
K141975 · GEX
Biolase, Inc.
General & Plastic Surgery · 227d
Cleared Mar 05, 2015
Nerve Monitoring Cable System
K142438 · PDQ
Pioneer Surgical Technology, Inc....
Neurology · 188d
Cleared Mar 05, 2015
Entriport
K142464 · GCJ
Conmed Corporation
General & Plastic Surgery · 184d
Cleared Mar 05, 2015
TraumaCad Mobile Release 1.0
K142923 · LLZ
Voyant Health, Ltd.
Radiology · 148d
Cleared Mar 05, 2015
Propeller System 2014-R
K142960 · CAF
Reciprocal Labs
Anesthesiology · 142d
Cleared Mar 05, 2015
QuantaFlo
K143094 · JOM
Semler Scientific, Inc.
Cardiovascular · 128d
Cleared Mar 05, 2015
NP Cement HV Genta
K143100 · LOD
Cossington, Ltd.
Orthopedic · 128d
Cleared Mar 05, 2015
NP Cement HV
K143134 · LOD
Cossington, Ltd.
Orthopedic · 125d
Cleared Mar 05, 2015
FOXTROT NC PTCA Balloon Catheter
K143160 · LOX
Shanghai MicroPort Medical (Group)...
Cardiovascular · 122d
Cleared Mar 05, 2015
Affix IIS Spinous Process Plate System
K143388 · PEK
Nu Vasive, Incorporated
Orthopedic · 99d
Cleared Mar 05, 2015
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
K143526 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 05, 2015
Visual-ICE Cryoablation System, Software Revision 1.3.1
K143564 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 79d
Cleared Mar 05, 2015
AccuLIF TL and PL Cage
K143616 · MAX
Stryker Corporation
Orthopedic · 76d