23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Revision Femoral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Symmetry Rochester Ochsner
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482039885·Symmetry® Forceps, Rochester Ochsner, Straight,...
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
AUDIT MICROCV RF/CRP LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 2, 2010
REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 25, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 25, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 26, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 31, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 31, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 14, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 26, 2019
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 23, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·August 27, 2019
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 21, 2020