8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LM 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPECTRONIC 2000 SPECTROPHOTOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DELTA CER HEAD 11/13 32MM +0
FDA Adverse Event
Injury
·DEPUY (IRELAND) 9616671·Product code LZO·June 6, 2014
VIRTUOSO DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 5, 2010
UNK - IOL
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·November 30, 2012
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·September 14, 2017
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022