19 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.

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)
FDA Class 3 ·Cardiovascular

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·September 4, 2025

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·September 4, 2025

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·September 4, 2025

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·September 4, 2025

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·September 4, 2025

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·August 28, 2025

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·September 4, 2025

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·September 21, 2023

CARDEON ASCENDING BALLOON CANNULA (ABC)

FDA 510(k)
FDA Class 2 ·Cardiovascular

NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 2, 2026

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 26, 2013

ACCURUS 400VS

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 22, 2011

GORE PROPATEN VASCULAR GRAFT

FDA Adverse Event
Other ·W.L. GORE & ASSOCIATES, INC·Product code DSY·July 23, 2008

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·March 17, 2016

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018