15 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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CYTETTE(TM) CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776178758·Gwilliam Clamp curved teeth, longitudinal ser...
ALLthread Titanium
FDA UDI
Biomet Orthopedics, LLC·00880304444263·
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOPANTOMOGRAPH OP30
FDA 510(k)
FDA Class 2
·Dental
5.0 ALLTHREAD TI 2#2 MB
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·July 12, 2023
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
ATLAS II HF CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 8, 2013
FG6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 18, 2010
980 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·September 13, 2024
980 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·January 2, 2024
980 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·January 2, 2024
QUATTRO LINK SP KNOTLESS ANCHOR 4.5MM PEEK ANCHOR WITH TITANIUM TIP
FDA Adverse Event
Malfunction
·CAYENNE MEDICAL·Product code MBI·May 1, 2024
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