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

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Reprocessed LigaSure Maryland Jaw Sealer/Divider

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

ORGENTEC RHEUMATOID FACTOR EIA

FDA 510(k)
FDA Class 2 ·Immunology

MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00

FDA 510(k)
FDA Class 2 ·Neurology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 24, 2023

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

FOOT CONTROL

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.·Product code LPB·August 15, 2019

GALAXY G3 MINI 2MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 MINI 1.5MM X 2CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 MINI 1.5MM X 2CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 MINI 1MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 MINI 1.5MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 XSFT 3MM X 4CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 MINI 1MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 MINI 2MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 MINI 1.5MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

GALAXY G3 MINI 1.5MM X 3CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017