20 results · 24ms · 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.

ETCO2 Sensor

FDA 510(k)
FDA Class 2 ·Anesthesiology

LULLABY

FDA 510(k)
FDA Class 2 ·General Hospital

POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS

FDA 510(k)
FDA Class 1 ·General Hospital

ASTRON CLEAR SPLINTS

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·December 17, 2019

GELB MOUTHGUARD

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·April 10, 2019

ASTRON CLEAR SPRINT

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·January 14, 2020

ASTRON CLEAR SPLINTS

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT INC.·Product code MQC·September 17, 2019

ASTRON CLEAR SPLINTS

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·December 17, 2019

ASTRON CLEAR SPLINTS

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·December 17, 2019

ASTRON CLEAR SPLINTS

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT INC.·Product code MQC·September 16, 2019

ASTRON CLEAR SPLINT

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·July 22, 2020

ASTRON CLEAR SPLINT LOWER

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·January 30, 2020

ASTRON CLEAR SPLINTS

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·May 4, 2020

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

6000 CMS IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 23, 2013

ASTRON CLEAR SPLINTS

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code MQC·July 2, 2020

BELIFU

FDA Adverse Event
Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

RING TRANSJUGULAR INTRAHEPATIC ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·November 15, 2019

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021