13 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V

FDA 510(k)
FDA Class 2 ·General Hospital

LEONE SPA

FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450473962·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450473986·

NEOCIF INSERTION INSTRUMENT

FDA Adverse Event
Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018

DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK

FDA 510(k)
FDA Class 2 ·General Hospital

NEOCIF INSERTION INSTRUMENT

FDA Adverse Event
Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017

SETROX S 45

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·May 4, 2011

PASSPORT 2 MONITOR

FDA Adverse Event
Malfunction ·MINDRAY USA, INC.·Product code MHX·April 30, 2013

GRANUFLO

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014

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

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018