14 results · 18ms · Sources: EU EUDAMED, US FDA

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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