27 results · 32ms · 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.

DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925040267·SICKLE KNIFE DISPOSABLE SINUS ENDOSCOPY

K133801

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024

n/a

FDA UDI
Ortho Development Corporation·00822409070312·Snap-on Fem Augment Trial 8mm Distal Size 3

K2M General Instruments

FDA UDI
VB Spine LLC·10888857562332·Lordotic Trial Size 22x50x7 mm, 8°

n/a

FDA UDI
Ortho Development Corporation·00822409066971·Stem Extension Trial Diameter 13x80mm

Portex

FDA UDI
ICU MEDICAL, INC.·15019517084030·

ADVIA Centaur® Cuvettes

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414221588·Laboratory analyser cuvette, IVD

Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder

FDA UDI
VASOMEDICAL, INC.·00817980020030·12 CH ECG Holter Ultra Recorder

BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PUMA MODEL VERSION 1.0

FDA 510(k)
FDA Class 2 ·Radiology

GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 24, 2013

UNIFY CRT-D, DF-4 CONNECTOR

FDA Adverse Event
Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

CAPIOX FX15

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·July 5, 2023

CAPIOX CUSTOM PACK

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·April 2, 2024