10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking
ACE VERSANAIL
FDA 510(k)
FDA Class 2
·Orthopedic
ACTIS ADJUSTABLE CONSTRICTION LOOP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
METRX® SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HRX·December 10, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
BRAT2 RESERVOIR W/OUTLET CLAP 30MCG FILTER
FDA Adverse Event
Injury
·SORIN GROUP·Product code DXE·September 10, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·May 3, 2011
METRX® SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·October 18, 2024
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