10 results · 21ms · Sources: EU EUDAMED, US FDA

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HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004

FDA 510(k)
FDA Class 2 ·Anesthesiology

Sklar®

FDA UDI
SKLAR CORPORATION·10649111116742·CUFF BLADDER BULB VALVE CHILD

ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT

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

HARDYDISK LEVOFLOXACIN, 5MCG

FDA 510(k)
FDA Class 2 ·Microbiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

PENEVAC, MEGADYNE E-Z CLEAN

FDA Adverse Event
Malfunction ·I.C. MEDICAL·Product code GEI·April 3, 2013

BREEZE2

FDA Adverse Event
Injury ·BAYER HEALTHCARE, LLC·Product code NBW·April 11, 2011

THERMOPHORE AUTOMATIC MOIST HEAT PACK

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT CO·Product code IRT·June 16, 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