13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COLLAGEN TENDON SHEET-D
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ArgenZ HT+ 98x18 D2
FDA UDI
ARGEN CORPORATION, THE·D818122048·Dental porcelain/ceramic restoration kit
Logical PX-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000363·
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATRAUMATIC VASCULAR CLAMPS
FDA 510(k)
FDA Class 2
·Cardiovascular
COTTON-HUIBREGTSE BILIARY STENT
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FGE·July 14, 2022
PROMUS ELEMENT ? LONG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 21, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011
ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·August 14, 2008
SAFESHEATH II 9F
FDA Adverse Event
Malfunction
·OSCOR INC.·Product code DYB·August 10, 2022
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014