20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRO TARGETING DRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327999·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327968·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033328002·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327982·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033327975·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033328019·
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·June 9, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·August 26, 2022
MINIMED MIO ADVANCE
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 11, 2025
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOCELLECT
FDA 510(k)
FDA Class 2
·Dental
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·April 3, 2024
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 3, 2023
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 22, 2022
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·March 19, 2013
SUPER POLIGRIP
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·February 21, 2011
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONDADUZ AG·Product code JTC·February 12, 2008
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
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019