9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
UTAH MEDICAL PRODUCTS, INC.·H6719026350·Arterial Blood Collection Kit, 48", 6cc, w/o DPT
APOLONIA LASER IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ALCATEL-LUCENT TELEHEATH MANAGER
FDA 510(k)
FDA Class 2
·Cardiovascular
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTR·May 9, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 18, 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