15 results · 28ms · Sources: EU EUDAMED, US FDA

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MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

AF811

FDA UDI
Respironics, Inc.·00606959008076·AF811 Mask, with Headgear, Small, Single Use

FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AMBULATORY ENTERAL NUTRITION PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

SEXTANT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·October 1, 2010

SSW CARBIDE CAD CAM

FDA UDI
Ss White Burs, Inc.·D690SSWAMG06304720022·CAD/CAM CARBIDE DURADI SSWAMG-063047-20-02 - 1...

SSW CARBIDE CAD CAM

FDA UDI
Ss White Burs, Inc.·D690SSWAMG06304720012·CAD/CAM CARBIDE LAZER SHARP SSWAMG-063047-20-01...

PROMUS ELEMENT¿ PLUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 17, 2013

STENOSCOP

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 21, 2011

CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·June 19, 2008

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 2025

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2023

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015