25 results · 23ms · Sources: EU EUDAMED, US FDA

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VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

FDA 510(k)
FDA Class 2 ·Immunology

PERFORMER 30 HPS

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

DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE

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

DREAMSTATION AUTO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·October 5, 2023

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 14, 2026

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·August 26, 2022

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·February 27, 2025

IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 10, 2024

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 8, 2013

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·March 9, 2011

INDURA

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code LKK·May 9, 2008

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·November 20, 2017

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·December 19, 2017

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·January 8, 2019

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·January 22, 2019

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·January 29, 2018

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code DQY·January 26, 2018

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·February 12, 2018

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·January 29, 2018

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·May 9, 2024