11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111156304·SCALPEL HANDLE #4L
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
FDA 510(k)
FDA Class 2
·Ophthalmic
MOLDED CRANIAL HELMET
FDA 510(k)
FDA Class 2
·Neurology
VECTRA GENISYS 2CH COMBO PKG
FDA Adverse Event
Injury
·DJO, LLC·Product code IMG·April 12, 2013
ISERT ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·March 21, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·June 19, 2008
RINGLOC BI-POLAR ACETABULAR CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWY·July 17, 2017
COAGUCHEK XS SYSTEM
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code GJS·August 10, 2020
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