13 results · 20ms · Sources: EU EUDAMED, US FDA

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INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003

FDA 510(k)
FDA Class 2 ·Anesthesiology

Optimotion Blue CR HCCR Total Knee System

FDA UDI
OPTIMOTION IMPLANTS LLC·B6961014P0619010·CR Tibial Insert, UHMWPE + Vitamin E, Size 6, ...

FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200

FDA 510(k)
FDA Class 3 ·Cardiovascular

POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM

FDA Adverse Event
Injury ·EV3 INC.·Product code NIP·April 16, 2013

SECURE 2 MED/SURGBED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·March 18, 2011

PROGRAMMING WAND

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·June 16, 2008

Ciaglia Blue Rhino

FDA UDI
COOK INCORPORATED·00827002300149·Ciaglia Blue Rhino Percutaneous Tracheostomy In...

Ciaglia Blue Rhino G2

FDA UDI
COOK INCORPORATED·00827002342781·Ciaglia Blue Rhino G2 Advanced Percutaneous Tra...

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

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018