11 results
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20ms
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Sources: EU EUDAMED, US FDA
EPICARDIA PC/FC
FDA 510(k)
FDA Class 2
·Cardiovascular
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403152368·Snowden-Pencer CURETTE FOX DERMAL 14CM 5-1/2 in...
SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77818831030·SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS
ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
FDA 510(k)
FDA Unclassified
·Unknown
EMS Belt (Model MC0485)
FDA 510(k)
FDA Class 2
·Physical Medicine
RGDFIX FEM3.3MM ST BR XPIN KIT
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·November 6, 2018
IAB: 8 FR - 40 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·October 15, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·February 7, 2014
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 21, 2012
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017