27 results · 19ms · Sources: EU EUDAMED, US FDA

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GULLIVER AND CLASSE A

FDA 510(k)
FDA Class 1 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743519·LEVAMED ANKLE SUPPORT SILVER III

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345023963·PADDLE SPREADER, 13MM

Battalion

FDA UDI
ALPHATEC SPINE, INC.·00840967186962·Battalion, LLIF Trial, 10°, 22 mm Wide, 13 mm X...

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033384022·

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0102130·Shaver, Open 13mm

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0142130·Trial, TLIF, 32L OB CRV 7Deg, 13mm

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0122100·T-Handle, Head Persuader

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132130·Trial, TLIF, 27L OB CRV 7Deg, 13mm

MODIFICATION TO CAVERMAP SURGICAL AID

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID

FDA 510(k)
FDA Class 2 ·General Hospital

SCP PANEL CENTRIFUGE JMS

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·November 5, 2013

SYNCHRON LX 20 PRO CLINICAL SYSTEMS

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 8, 2011

SCP PANEL CENTRIFUGE JMS

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·March 14, 2014

SCP CONTROL PANEL

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012

CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWA·January 19, 2018

CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWA·January 5, 2022

STOCKERT JMS CENTRIFUGAL PUMP SYSTEM

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012

PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.

FDA Enforcement
Class II ·Terminated·Unimed Surgical Products, Inc.·May 29, 2013

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007