35 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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SPIFE CHOLESTEROL PROFILE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Preat Implant Prosthetics
FDA UDI
Preat Corporation·00842092156773·NobelBiocare™ Tri-Lobe-compatible WP Digital An...
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741121173·Catheter Placement Kit
GC Reline ™
FDA UDI
Gc America Inc.·D0470006031·GC Reline ™ Modifier, 1-1 Pack, A&B 10 g (9 mL)...
N/A
FDA UDI
Ortho Development Corporation·00822409090341·Alpine Reamer 13-14
Tooth Tone
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730014801·NiTi Coated Upper 018 10 archwires per pack
Implant Prosthetics
FDA UDI
Preat Corporation·00842092134733·NobelBiocare™ Tri-Lobe-compatible WP Digital An...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092134726·NobelBiocare™ Tri-Lobe-compatible WP Digital An...
4WEB Medical
FDA UDI
4web Medical·00812998040131·
FlowLogic Assert
FDA UDI
SONENDO, INC.·00810209420437·FlowLogic Assert Shaping File 10/.04, 21mm
AVL OPTI R ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TORNIER TOTAL ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
SOLACE Sacroiliac Fixation System
FDA UDI
XENIX MEDICAL LLC·00818345029330·12mm Implant Guide to Pin Guide, 18mm
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522110252·LDWR,SET,SHLD,PNCH,3-LEAD,102CM/40IN,IEC,1/ST
PTERYFIT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LRD·Product code DZE·May 1, 2024
PTERYFIT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·July 9, 2024
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·March 12, 2013
TRIAGE PROFILER SOB 25 TEST KIT
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code MMI·February 2, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·February 15, 2008
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016