12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed Inquiry Steerable Diagnostic EP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)
CREATININE PLUS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDTRONIC NAVIGATION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·February 21, 2025
BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·April 21, 2022
ACUSNARE POLYPECTOMY SOFT SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·October 10, 2008
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013
ALIYA
FDA Adverse Event
Injury
·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021