10 results · 23ms · 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.

TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

MIZAR, BASIS BE, SANDMAN DIGITAL

FDA 510(k)
FDA Class 2 ·Neurology

MARK II/MARK III MANOMETRIC PERFUSION PUMP

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EDWARDS ESHEATH INTRODUCER SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021

EDWARDS TF SHEATH UNKNOWN

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 3, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM)

FDA Adverse Event
Malfunction ·BARD ACCESS SYSTEMS·Product code FOZ·August 21, 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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015