11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TEH LIN JUPITER POWER CHAIR, MODEL TL-320
FDA 510(k)
FDA Class 2
·Physical Medicine
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 17, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·June 18, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 12, 2011
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·September 10, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015