10 results
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19ms
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Sources: EU EUDAMED, US FDA
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750001743·VITROS Chemistry Products BARB Reagent
ACUMED
FDA UDI
Acumed LLC·10806378052859·Hand Plates Caddy Lid
HEAL FORCE CO2 INCUBATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODULAR
FDA 510(k)
FDA Class 2
·Anesthesiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 23, 2012
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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