11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496061229·BURLESQUE 70, SIZE S, GLACE, GRADUATED COMPRESS...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612291·Mini Sprint II Brackets FACE Evolution II Syste...
DEVILBISS 9000 SERIES CPAP, MODEL 9001
FDA 510(k)
FDA Class 2
·Anesthesiology
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
FDA 510(k)
FDA Class 2
·Immunology
COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 16, 2013
XENMATRIX
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTM·April 11, 2011
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 14, 2017
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