10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
FDA 510(k)
FDA Class 2
·General Hospital
NOVOTWIST 8 MM (30G)
FDA Adverse Event
Injury
·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·August 11, 2016
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
FDA 510(k)
FDA Class 2
·Ophthalmic
SONOPSY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
METRX® SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·October 3, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
1/4 INCH SMALL PATIENT
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DWE·August 21, 2014
INTEGRITY RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MAF·April 14, 2011
METRX® SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HRX·October 15, 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