10 results · 21ms · Sources: EU EUDAMED, 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