9 results · 22ms · Sources: EU EUDAMED, US FDA

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DUREX PLAY MASSAGE GEL LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE

FDA 510(k)
FDA Class 2 ·Orthopedic

TWILITE, TWILITE WHITE

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

CAPIOX SX OXYGENATOR W/ HR X COATING

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTN·April 11, 2013

MINICAP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·April 19, 2011

JOSTENT GRAFTMASTER

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·June 19, 2008

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