9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUREFLEX STEERABLE GUIDING SHEATH KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
FDA 510(k)
FDA Class 2
·Cardiovascular
GEMORE MUSCLE CONDITIONER;
FDA 510(k)
FDA Class 2
·Physical Medicine
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
FDA 510(k)
FDA Class 2
·Neurology
AMISTEM H, HA COATED STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 19, 2017
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 21, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 26, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 14, 2011
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013