11 results · 20ms · Sources: EU EUDAMED, US FDA

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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