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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WasherCap Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
AIRCAST
FDA UDI
DJO, LLC·00888912008884·ACC, CRYO/CUFF IC LID
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250238200·ceraMotion® Zr Chroma Concept Dentin 8, 20 g / ...
SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ControlRad Sterile Cover
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MSS - HUMERAL REVERSE LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 14, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013