20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PREMIER ULTRASONIC SCALER AND INSERTS
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776398842·Posterior Condylar Retractor, 50mm x 6.5mm, OL ...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036006860·
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101150·Distractor, Smooth Paddle, Lordotic, 15mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101150·Distractor, Smooth Paddle, 15mm
CRANIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR
FDA 510(k)
FDA Class 1
·General Hospital
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 13, 2025
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·March 19, 2013
SECURE 2 MED/SURGBED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 1, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·March 10, 2008
YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
FDA Adverse Event
Injury
·COOK INC·Product code GAA·January 11, 2017
YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
FDA Adverse Event
Injury
·COOK INC·Product code GAA·January 11, 2017
YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
FDA Adverse Event
Injury
·COOK INC·Product code KDD·January 11, 2017
YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
FDA Adverse Event
Death
·COOK INC·Product code GAA·January 11, 2017
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·June 3, 2015
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC·Product code MIH·June 9, 2015
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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013