19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
FDA 510(k)
FDA Class 2
·Radiology
INFINITY EXPLORER
FDA 510(k)
FDA Class 2
·Cardiovascular
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
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 17, 2013
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·June 19, 2008
2 LEAD SOLUTION ADMINISTRATIONSET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·April 19, 2011
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·January 14, 2026
ASSY,ENGLISH,DOMSTC,110V,SYS98
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 15, 2025
ADVIA CENTAUR HBSAGII (HBSII)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·November 2, 2021
ADVIA CENTAUR HBSAGII (HBSII)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·November 2, 2021
SENSATION 7FR. 34CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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