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