13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Stryker GmbH·00886385005522·Cortical Screw, Non-Lock., Self-tap., T6 Drive
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868074·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356689·
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
FDA 510(k)
FDA Class 1
·General Hospital
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 3, 2019
ADVIA 1800
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·April 6, 2011
FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·April 9, 2013
VITALITY DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
ZILVER 518 SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2012
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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