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