13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EUROIMMUN ANTI BP 180-4X ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
Zavation
FDA UDI
Zavation LLC·00842166106123·ALIF 8deg 36mmx15
ZAVATION
FDA UDI
Zavation LLC·00842166157118·HA+ ALIF 8deg 36mmx15
Zavation
FDA UDI
Zavation LLC·00842166180567·ALIF Sizer 8deg 36mm x 15mm
ZAVATION
FDA UDI
Zavation LLC·00842166154896·WHITNEY 8deg 36mmx15mm
MICRO-INDUCTION 1000 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 10, 2011
CELL-DYN WBC REAGENT A
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·July 29, 2008
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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