11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
FDA 510(k)
FDA Class 2
·Radiology
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·10612479260464·PED ANCILLARY 450 DOSE MASTER CONVENIENCE KIT
Oticon
FDA UDI
Oticon A/S·05707131339089·SIYA 1, MRITE 312 2.4G NFM PB C090
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807190461101·IN-OVATION® L 018/LL 6&7 0T 0A HK
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
FDA 510(k)
FDA Class 2
·Radiology
MAMBA? FLEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014
JINDO STEERABLE GUIDEWIRE
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code DQX·June 26, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024