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

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SYNERVIEW MODEL 6478

FDA 510(k)
FDA Class 2 ·Radiology

OMNIARCH®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055611·OMNIARCH® EURO 022 UL/5-5 CS HK

OMNIARCH®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055221·OMNIARCH® Base Rx 022 UL/5-5 CS-BC HK

OMNIARCH®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055621·OMNIARCH® EURO 022 UL/5-5 CS-BC HK

OMNIARCH®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055131·OMNIARCH® Base Rx 018 UL/5-5 CS HK

OMNIARCH®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055121·OMNIARCH® Base Rx 018 UL/5-5 CS-BC HK

OMNIARCH®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055281·OMNIARCH® CETLIN® 022 UL/5-5 CS HK

OMNIARCH®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055231·OMNIARCH® Base Rx 022 UL/5-5 CS HK

OMNIARCH®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055301·OMNIARCH® BI-DIMENSIONAL® UL/5-5 CS HK

T-Rex Standalone ALIF

FDA 510(k)
FDA Class 2 ·Orthopedic

SLEEP QUALITY

FDA 510(k)
FDA Class 2 ·Anesthesiology

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 3, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 27, 2007

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·April 24, 2014

COVEREDGE? 32

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 5, 2026

Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021