12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEMIO XG, SAA-580A
FDA 510(k)
FDA Class 2
·Radiology
Acapella One
FDA UDI
Choice Spine, LP·00840996151023·ACAPELLA,TRIAL,PA,NS,14X16X5
MEDGEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SPRINT QUATTRO
FDA Adverse Event
Death
·MPRI·Product code LWS·April 16, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KRL·June 17, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 18, 2011
MurphyScope, Curved, Mallaeble, Catalog # 2125-163
FDA Recall
Terminated
·Medtronic Neurosurgery·Product code GWG·February 28, 2005
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024