16 results · 24ms · Sources: EU EUDAMED, US FDA

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Refobacin Bone Cement R (110034355)

FDA 510(k)
FDA Class 2 ·Orthopedic

Poly Per-Q-Cath Catheter

FDA UDI
Bard Access Systems, Inc.·00801741035012·DOT POLY PQC, 4F, DL,

Kleiner KG2 system

FDA UDI
Baat Medical Products B.V.·08720246783117·Shaver

XO CROSS CORONARY Support Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2011

GYNECARE TVT SECUR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code PAH·July 30, 2013

PLATE BBL CHROMAGAR ORIENTATION

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSH·November 14, 2024

PLATE BBL CHROMAGAR ORIENTATION

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSH·November 14, 2024

PLATE BBL CHROMAGAR ORIENTATION

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSH·November 14, 2024

BBL CHROMAGAR ORIENTATION 90MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSH·January 13, 2025

KOH-EFFICIENT,ARCH,4.0CM

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code HEW·December 18, 2018

PLATE BBL CHROMAGAR ORIENTATION 90MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSH·November 19, 2024

STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·December 19, 2012

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026