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