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