11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VENTED VIAL ADAPTER TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 16, 2021
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·April 28, 2021
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 4, 2021
VISION 9000 PHASED ARRAY TORSO COIL
FDA 510(k)
FDA Class 2
·Radiology
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 17, 2013
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·April 7, 2011
UNKNOWN DUPUY SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HWC·June 17, 2008
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