15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Alma Diode Tabletop Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO SYNTHES MATRIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COLLAGEN NERVE WRAP
FDA 510(k)
FDA Class 2
·Neurology
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 22, 2020
FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 23, 2018
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·June 16, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 10, 2014
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 23, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 23, 2013
CORAIL AMT COLLAR SIZE 9
FDA Adverse Event
Injury
·DEPUY FRANCE SAS - 3003895575·Product code KWA·February 7, 2012
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·January 18, 2016
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 7, 2013
5.5MM TI CURVED ROD 45MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017