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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040007754·Zirlux 16+ A2 89x17x10

MedStream

FDA UDI
MEDICAL SPECIALTIES DISTRIBUTORS, LLC·00842472101188·DRESSING CHANGE KIT/CHG 1STEP/AMDDISC/PF

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 3, 2024

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 5, 2024

STA-LIATEST FREE PROTEIN S TEST KIT

FDA 510(k)
FDA Class 2 ·Hematology

MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

BD LUER-LOK

FDA Adverse Event
Injury ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 18, 2025

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 23, 2024

CM ALVIM ACQUA IMPLANT 3.5X8

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·May 25, 2018

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 20, 2013

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 14, 2011

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LDD·March 11, 2008

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 5, 2026

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 5, 2026

5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML

FDA Adverse Event
Death ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FOZ·July 12, 2018

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

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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