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

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SURGICAL HEADLIGHT

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

MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY

FDA 510(k)
FDA Class 2 ·Radiology

PROTECTIV SAFETY BLOOD COLLECTION NEEDLE

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

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 16, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·April 18, 2011

ACCU-CHEK MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·January 3, 2008

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·February 16, 2017

LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·July 10, 2017

LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·December 4, 2017

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DQX·February 9, 2017

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DQX·December 19, 2018

LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·April 20, 2017

LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DQX·June 16, 2017

LUNDERQUIST SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DQX·May 31, 2017

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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