24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FULL HEMISPHERE RING-LOC LINER
FDA 510(k)
FDA Class 2
·Orthopedic
Clydesdale™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994972668·CAGE 2920640 CLYDESDALE 22 0 DEG 16X40
CLYDESDALE PTC™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169190917·CAGE 4920640 CDALE PTC 22MM 0 DEG 16X40
Liofilchem MTS (MIC Test Strip)
FDA UDI
LIOFILCHEM SRL·18055182872166·
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110997·DOUBLE PLASTIC STERILIZATION CASE
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122819·K-WIRE - DOUBLE TROCAR 0.6mm DIA x 100mm
INSUFLOW SYNERGY PORT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KSEA SCB MEDIA CONTROL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LARGE AO COUPLING ASNIS III HALL FITTING
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 25, 2012
ENDOTRACHEAL TUBE 7.5 MM EMG FLEX
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code BTR·July 28, 2010
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·December 16, 2013
BLEASE FOCUS ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SPACELABS MEDICAL INC.·Product code BSZ·January 17, 2013
PROXIMATE*ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 13, 2010
ENDURITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
ENDOTRACH TUBE 8229306J NIM EMG 6MM
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC·Product code ETN·March 6, 2013
ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·May 10, 2013
REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 17, 2013
ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·March 11, 2013
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·August 26, 2013
XP-XP Tibial Tray - Interlok 83 mm Item # 195759
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019