10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMPTY MIXING CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
Nu-Edge Metal Bracket
FDA UDI
TP ORTHODONTICS INC·00192029046791·LL 1st BI NO HK
MODIFIED TREVO PROVUE RETRIEVER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MARGRON STEM (K032641)
FDA Adverse Event
Injury
·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
RAD-8
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 17, 2015
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 29, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 14, 2014
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024