12 results · 22ms · Sources: EU EUDAMED, US FDA

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Everest Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ø3.5mm x 8mm Lateral Mass Screw with Set Screw

FDA UDI
XENCO MEDICAL LLC·B064XM21735081·Ø3.5mm x 8mm Lateral Mass Screw with Set Screw ...

UNMIAX LAPAROSCOPIC INSTRUMENT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PARKONE

FDA 510(k)
FDA Class 2 ·Ophthalmic

SYMBIQ 3.13 DUAL CHA

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014

S-ROM*SLEEVE PRX ZTT, 18B-LRG

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 17, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTC·February 4, 2022

ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTC·February 4, 2022

ALINITY S HBSAG REAGENT KIT

FDA Adverse Event
Injury ·ABBOTT IRELAND·Product code QHM·October 4, 2022

ALINITY S HBSAG REAGENT KIT

FDA Adverse Event
Injury ·ABBOTT IRELAND·Product code QHM·November 29, 2022

7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·July 26, 2017