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

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COCAINE DIPSTICK TEST, MODEL D747-A

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

HANISCH MEDICAL

FDA UDI
Hanisch Medical Ltda·07901089813082·H49-TRAY F/INST.STANDER---BEIGE

JOE FRESH

FDA UDI
FGX INTERNATIONAL INC.·00193033117491·

JOE FRESH

FDA UDI
FGX INTERNATIONAL INC.·00193033117569·

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345023925·PADDLE SPREADER, 9MM

JOE FRESH

FDA UDI
FGX INTERNATIONAL INC.·00193033117507·

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0102090·Shaver, Open 9mm

JOE FRESH

FDA UDI
FGX INTERNATIONAL INC.·00193033117613·

JOE FRESH

FDA UDI
FGX INTERNATIONAL INC.·00193033117118·

JOE FRESH

FDA UDI
FGX INTERNATIONAL INC.·00193033117484·

ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016

SMALL BATTERY DRIVE

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HWE·March 19, 2013

MEDISENSE OPTIUM

FDA Adverse Event
Malfunction ·Product code NBW·March 8, 2011

MALLINCKRODT

FDA Adverse Event
Injury ·TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT DIVISION·Product code BTR·March 7, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·H10·Product code KWP·April 4, 2013

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

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014