10 results
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33ms
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Sources: EU EUDAMED, US FDA
DEHYDROEPIANDROSTERONE SULFATE KIT RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACUMED
FDA UDI
Acumed LLC·10806378095337·12mm x 16mm Concave Joint Reamer
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776122942·Bipolar Forcep
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FORAMATRON V, MODEL D680
FDA 510(k)
FDA Unclassified
·Unknown
LINEAR CUTTERS - NTLC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007
SAPPHIRE MULTI THERAPY INFUSION PUMP
FDA Adverse Event
Injury
·Q CORE MEDICAL LTD·Product code FRN·May 27, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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