11 results
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17ms
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Sources: EU EUDAMED, US FDA
PULSED SELECTRON
FDA 510(k)
FDA Class 2
·Radiology
ERA 3.25MM IMP 0DEG MICRO HEAD 15X4MM ACID ETCH, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109829·Designed for both transitional and long-term de...
Seiva
FDA UDI
SUNTECH MEDICAL, INC.·10840935109990·
FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TCD 100M, PWD13 TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 30, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·November 12, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·November 12, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
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