12 results
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26ms
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Sources: EU EUDAMED, US FDA
O.R. ARMBOARD COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130300·X Plate - Ø1.9 mm - 6 hole - 18 mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130300·Wrench, Derotation, Double Ended
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197322034·Jurasz laryngeal polypus forcpes Fig. 3
220mm,...
Bioplate®
FDA UDI
Bioplate, Inc.·M384813030US0·X Plate - Ø1.9 mm - 6 hole - 18 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384813030CP1·X Plate - Ø1.9 mm - 6 hole - 18 mm
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
FDA 510(k)
FDA Class 2
·Microbiology
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 15, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 31, 2012
REPAIR CORE SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·August 12, 2010
Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. Gebauer's Fluro-Ethyl is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.
FDA Recall
Terminated
·Gebauer Company·Product code MLY·September 3, 2008