10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.)
FDA 510(k)
FDA Class 1
·Microbiology
SMR SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code KWT·October 21, 2025
SPARTAN A-10
FDA 510(k)
FDA Class 2
·Dental
FUTURABOND M/FUTURABOND M SINGLE DOSE
FDA 510(k)
FDA Class 2
·Dental
GEMSTAR PAIN MGE SNG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
ROTH NET PLATINUM FOOD BOLUS RETRIEVER
FDA Adverse Event
Malfunction
·US ENDOSCOPY·Product code KOG·September 17, 2012
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010
BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·January 9, 2019
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
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