10 results
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32ms
·
Sources: EU EUDAMED, US FDA
MODEL 340GE-21C QUADRATURE BRAIN COIL
FDA 510(k)
FDA Class 2
·Radiology
Q4000 OPTION FOR Q4000
FDA 510(k)
FDA Class 2
·Cardiovascular
TIGER PATIENT EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 2, 2013
VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·February 28, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 9, 2011
ARCTIC SUN
FDA Adverse Event
MEDIVANCE, INC·Product code DWJ·July 21, 2014
11.0MM TI HELICAL BLADE 105MM-STERILE
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·December 5, 2014
12/14 ARTICUL 40MM M SPEC+1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 2, 2013
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018