19 results
·
28ms
·
Sources: EU EUDAMED, US FDA
CPS-3000 CARDIOPLEGIA RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694032896·EnCompass Lesser .071 Guide Pin
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746032622·SUPPLIES - IMPRESSION TRAY UPPER LARGE BLUE 20/PKG
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162886·SUPPLIES - IMPRESSION TRAY UPPER LARGE BLUE 20/PKG
Impression Tray
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746034992·SUPPLIES - IMPRESSION TRAY UPPER LARGE BLUE 20/PKG
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861102220·Standard Band, Tooth 44/34, Size 2/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861102180·Standard Band, Tooth 44/34, Size 2/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861102000·Standard Band, Tooth 45-44/34-35, Size 2
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 7, 2006
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code FZP·June 15, 2006
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code FZP·June 8, 2006
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code FZP·June 7, 2006
Nanostim Introducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
PRIMA ANAESTHESIA MACHINE
FDA 510(k)
FDA Class 2
·Anesthesiology
PROTECTA VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
ENDOTAK PLUS
FDA Adverse Event
Malfunction
·HISTORICAL PUERTO RICO·Product code NVY·October 8, 2010
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 4, 2012
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012