12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONSTER SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
FDA 510(k)
FDA Class 2
·Physical Medicine
PILAIRO NASAL PILLOWS MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 8, 2019
BIHAPRO FEM PMMA CNTRLZR 13MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·July 24, 2019
DELTA CERAMIC FEM HD 028/ 0MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 24, 2019
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 17, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 27, 2014
ARCOM 28MM RNGLOC LNR HWALL 23
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·July 24, 2019
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·April 8, 2015
QUADRA H CEMENTLESS FEMORAL STEM SIZE 4 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 11, 2015