30 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CASPIAN SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MILLER BONE RASPATORY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896052406·MILLER BONE RASPATORY DOUBLE ENDED CROSS SERRAT...
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642129861·PS3 Tap, 5.0mm, NAV-M
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
FDA 510(k)
FDA Class 1
·General Hospital
CYBERCASES BY BAUSCH & LOMB
FDA 510(k)
FDA Class 2
·Ophthalmic
AMISTEM H HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 29, 2018
STEM: AMISTEM HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 30, 2019
AMISTEM H, HA COATED STEM SIZE 5 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 13, 2017
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 9, 2013
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 19, 2014
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 25, 2011
DELTAFILL18 10MM X 40CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
Artis Q floor, Model Number 10848280
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
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018