22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FUSION Plus Curing Light
FDA 510(k)
FDA Class 2
·Dental
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304269033·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239380·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694090988·X Plate, Xsmall
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306821370·Bi-Polar Cushing Forceps, Bayonet, 0.5mm Tip, 1...
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987169101·CORTICAL SHANK, Cannulated, 8.0 X 65
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981169107·CORTICAL SHANK, Cannulated, 8.0 X 65
SSW Carbide Fissurotomy
FDA UDI
Ss White Burs, Inc.·D6901800652·FG SNCLF - 5 PACK
Sochi
FDA UDI
Altus Spine, LLC·00843210173849·Rod, 3.5mm x 65mm
SPAULDING IQ ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
OSFERION
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
UNKNOWN DEPUY SZ 3 FB TIB TRAY
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 20, 2013
INPECO SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code JQP·July 27, 2011
PUMP MMT-515NAB PRDGM INS V2.1 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·September 26, 2008
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 3, 2021
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022