10 results · 20ms · Sources: EU EUDAMED, 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