18 results · 22ms · Sources: EU EUDAMED, US FDA

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RETISCAN, RETIPORT

FDA 510(k)
FDA Class 2 ·Neurology

VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)

FDA 510(k)
FDA Unclassified ·Unknown

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

DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDI·March 27, 2013

NEXGEN LPS POROUS FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·March 16, 2011

GASTROSTOMY TUBE

FDA Adverse Event
Malfunction ·ROSS PRODUCTS DIVISION·Product code KNT·April 2, 2008

T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation

FDA Enforcement
Class II ·Terminated·Vidacare Corporation·June 24, 2015

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

ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIU·September 5, 2023

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018