10 results · 19ms · Sources: EU EUDAMED, US FDA

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HILAL EMBOLIZATION MICROCOIL(TM)

FDA 510(k)
FDA Class 2 ·Neurology

OnBrace Crown LR7 (5/pk)

FDA UDI
SPECIALTY APPLIANCES, LLC·D8199013370·

INTEGRATED NEEDLEHOLDER

FDA UDI
SONTEC INSTRUMENTS, INC.·B09929013370·NEEDLE-HOLDER WITH TUNGSTEN CARBIDE INSERTS CRO...

DANIELS SHARPSMART REUSABLE SHARPS CONTAINER

FDA 510(k)
FDA Class 2 ·General Hospital

A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

ALARIS SE PUMP ADMINSTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORPORATION·Product code FPA·November 10, 2010

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 8, 2013

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

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021