8 results · 28ms · 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.

VIP ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BONUS MECHANICAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

HF MODULE WITH TRANSDUCERS

FDA 510(k)
FDA Class 2 ·Radiology

FORTIFY DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 14, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

COROX OTW 75-BP

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG,·Product code NKE·April 29, 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

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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