19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JAZZ SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDO-EXPRESS (R) HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMISTEM HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 13, 2020
VA LOCKSCR Ø2.4 SELF-TAP L16 TAN
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·May 21, 2013
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Malfunction
·OPTONOL, LTD·Product code KYF·July 29, 2014
ADJUSTABLE PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·May 6, 2011
AMISTEM H FEMORAL STEM SIZE 5 STANDARD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·October 15, 2012
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code MAF·March 26, 2010
Dimension Vista Estradiol (E2) Flex reagent cartridge
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·August 13, 2010
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·August 13, 2010
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·August 13, 2010
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·August 13, 2010
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·August 13, 2010
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·August 13, 2010
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 22, 2017
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 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