10 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AEROMIST II NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
MICRO SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929013150·MICRO SCISSORS STRAIGHT SINGLE-ACTION JAW
MODIFICATION TO KION ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
COVIDIEN EXTENDED TIP APPLICATOR
FDA 510(k)
FDA Class 2
·General Hospital
GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 6, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·November 17, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·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