14 results
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18ms
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Sources: EU EUDAMED, US FDA
ADT SOFT TISSUE BIOPSY TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MGB Alert® EBV Primer Mix ASR - 48 Reactions
FDA UDI
Elitechgroup Mdx LLC·03661540951480·"MGB Alert® EBV Primer Mix contains chemically ...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756016063·ARM SLING
MGB Alert EBV Primer Mix ASR, 09N39-003
FDA UDI
Elitechgroup Mdx LLC·03661540950131·MGB Alert® EBV Primer Mix contains chemically s...
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742103068·ADARA ø4.5mm Cortical Screw, Full Thread, Self-...
PROTOE ENDOSORB SMALL HAMMER TOE PIN
FDA 510(k)
FDA Class 2
·Orthopedic
MEDISUL DISPOSABLE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNSPECIFIED BY THE COMPLAINANT
FDA Adverse Event
Injury
·COOK BIOTECH, INCORPORATED·Product code PAG·April 3, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 22, 2012
ETS FLEX ARTICNG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 16, 2010
Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015