40 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDICAL MAGGOTS, LESOC
FDA 510(k)
FDA Unclassified
·Unknown
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964073380·Endo Carry-On Procedure Kit
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450191781·
PORTA AURIUM, MODEL 2067
FDA 510(k)
FDA Class 2
·Dental
MAC ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
AGX
FDA UDI
Widex A/S·05706069749038·Audigy AGXWU-FP (Winter silver S-220 ) Telecoil...
GMK FIXED PS TIBIAL INSERT SIZE 3 - 14 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·January 8, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012
QUADRA P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 26, 2023
BALL HEADS: BIPOLAR HEAD Ø28X51
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWY·April 7, 2022
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 25, 2016
28MM DIA COCR MOD HD -3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 9, 2013
PINNACLE MTL INS NEUT36IDX62OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.8010379·Product code KWA·September 19, 2014
PENUMBRA SYSTEM REPERFUSION CATHETER 032
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·April 12, 2011
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 30, 2022
CROSSTIE
FDA Adverse Event
Malfunction
·CROSSROADS EXTREMITY SYSTEMS·Product code HWC·September 29, 2022
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·September 5, 2012