8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TISSUE-TEK V.I.P. 100/200
FDA 510(k)
FDA Class 1
·Pathology
Couture Essence
FDA UDI
Carolon Company·00078301831333·
TMC ELECTRICAL SCOOTER, EASY 405
FDA 510(k)
FDA Class 2
·Physical Medicine
ACTIVE BREATHING COORDINATOR
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 25, 2007
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
FDA Enforcement
Class II
·Terminated·Polymer Technology Systems, Inc.·March 11, 2020