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

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ECHELON OVAL MRI SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Oticon

FDA UDI
Oticon A/S·05707131202697·GET, BTE P 13 CBE

BIO-MODULAR / BI-POLAR SHOULDER

FDA UDI
Biomet Orthopedics, LLC·00880304007802·

JOBST forMen Casual

FDA UDI
BSN MEDICAL, INC.·00035664131456·FOR MEN CASUAL 30-40 MM HG KNEE HIGH CLOSED TOE...

DD tempMED

FDA UDI
Dental Direkt GmbH·EDDIK113151·DD tempMED are pre-colored dental milling blank...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197116893·Trautmann Gouge, 5mm 140mm,...

ONE TOUCH BASIC ENHANCED

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·March 1, 2002

HAMMERLOC TM TIBIAL FIXATION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 11, 2023

PAGEWRITER TC 20 CARDIOGRAPH

FDA Adverse Event
Malfunction ·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·April 13, 2017

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·May 9, 2013

IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

TANNING BEDS

FDA Adverse Event
Injury ·UNK·Product code LEJ·May 29, 2011

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

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

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

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