26 results · 28ms · Sources: EU EUDAMED, US FDA

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CHALLENGE-EVER

FDA 510(k)
FDA Class 1 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814664·GENUMEDI SILVER SIZE III

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814206·GENUMEDI PT SILVER L III

REPICCI II RESURFACING KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304447127·

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664008581·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...

Zemits YAGenix

FDA UDI
Advance-Esthetic LLC·00860013757533·

Diagon

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO1022230·Trial, Bi-Convex,10 x 34mm, 12mm

EPIC SPO2 FINGER SENSOR, MODEL E412-20

FDA 510(k)
FDA Class 2 ·Cardiovascular

CG-2211 SELFCHECK ECG TRANSMITTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 29, 2023

T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·July 27, 2017

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

CLINICAL INFORMATION CENTER

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code DSI·May 19, 2011

UNIVERSAL DRIVER

FDA Adverse Event
Malfunction ·ABBOTT SPINE, INC.·Product code HXX·August 7, 2008

GORE-TEX® SUTURE

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code GAW·February 10, 2026

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·June 11, 2025

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

Model Number L101, ESSENTIO DR SL Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021