13 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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INFILL GRAFT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176148056·Bone Cutter type 163 HP
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213026353·microSelectron Transfer Tube for 6F Flexibles (22)
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
LUCENT OR LUCENT MAGNUM
FDA 510(k)
FDA Class 2
·Orthopedic
METAFLEXCOIL
FDA 510(k)
FDA Class 2
·Radiology
ASKU
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·February 15, 2011
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·May 6, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011
STERLING MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·August 13, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021