20 results · 23ms · Sources: EU EUDAMED, 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