10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FEMTEN CERVICAL TENACULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040119799·NITINOL RIGHT FORM NATURAL ARCHWIRE .014 UPPER
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
FDA 510(k)
FDA Class 2
·Immunology
DEEP GRAY
FDA 510(k)
FDA Class 2
·Radiology
TRANSPAC
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC·Product code DRS·April 9, 2013
SMART SET INFUSION SET
FDA Adverse Event
Malfunction
·ALARIS MEDICAL SYSTEMS, INC.·Product code FPA·May 31, 2008
IM REAMER, AO FITTING 10,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·April 7, 2011
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018