10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROVAC
FDA 510(k)
FDA Class 2
·General Hospital
ACUMED
FDA UDI
Acumed LLC·10806378046896·Depth Gauge 10-150mm
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209117338·
GAZELLE BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
FDA 510(k)
FDA Class 1
·Ophthalmic
INTERBODY INSERTER CAPSTONE & CLYDESDALE
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·May 8, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 23, 2012
MAVERICK2 BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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