12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
XR90 (XR90-SYS)
FDA 510(k)
FDA Class 2
·Radiology
ORTHOCORD
FDA UDI
Medos International Sàrl·10886705022939·ORTHOCORD Violet Braided Composite Suture BB 17...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113905·VISCO INJECTION CANNULA 25GA
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331168734·mathieu needle holder, spring handles, serrated...
COALESCENT U-CLIP- AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GE DATEX-OHMEDA AVANCE CS2
FDA 510(k)
FDA Class 2
·Anesthesiology
CLINITEK STATUS+
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
ATLANTIS (TM) SR PRO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·August 25, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 12, 2013
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018