10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cirq Arm System (2.0);Alignment System Spine
FDA 510(k)
FDA Class 2
·Neurology
XP200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROXILOCK HIP PROSTHESIS; SIZE 12/36
FDA 510(k)
FDA Class 2
·Orthopedic
LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 19, 2012
TENDRIL DX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·Product code OYC·July 12, 2013
SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
FDA Enforcement
Class II
·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·October 31, 2012
SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·September 6, 2012
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018