12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRIMA TT Glenoid
FDA 510(k)
FDA Class 2
·Orthopedic
HEALIX ADVANCE
FDA UDI
Medos International Sàrl·10886705030613·HEALIX ADVANCE SP PEEK ANCHOR 6.5mm
CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
CONTOUR SE MICROSPHERES
FDA 510(k)
FDA Class 2
·Neurology
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 5, 2008
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 14, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 12, 2013
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 15, 2013
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 15, 2013
MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2022
UNK - SCREWS: LOCKING
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·September 22, 2020
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014