20 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496063025·SOCKS FOR YOU BAMBOO OPERA, SIZE XXL, GRIGIO, G...
Symmetry Semkin
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482052266·Symmetry® Forceps, Semkin, Curved, Serrated, 6 in
MODIFICATION TO FLOUROLAB PLUS
FDA 510(k)
FDA Class 2
·Neurology
SELF SEAL STERILIZATION POUCH
FDA 510(k)
FDA Class 2
·General Hospital
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 24, 2022
SYSTEM 98XT, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 3, 2026
SYSTEM 98XT
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 22, 2025
ASSY,ENGLISH,DOMSTC,110V,SYS98
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·December 26, 2025
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 3, 2025
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 18, 2025
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 17, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 21, 2011
PATIENT RETURN GROUNDING PAD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ODR·June 19, 2008
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·January 14, 2026
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·August 1, 2013
ASSY,ENGLISH,DOMSTC,110V,SYS98
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 15, 2025
SENSATION 7FR. 34CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015