10 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
FDA 510(k)
FDA Class 2
·Hematology
ERA ANGLE 3.25MM IMP MICRO HEAD 13X1MM ACID ETCHED, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109638·Designed for both transitional and long-term de...
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXI-SEAL CONTROL FMS KIT US
FDA Adverse Event
Malfunction
·CONVATEC, INC.·Product code KNT·May 7, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 3, 2015
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC.·Product code NQO·October 22, 2010
OT SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 6, 2010
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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