27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WoundExpress
FDA 510(k)
FDA Class 2
·Cardiovascular
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112143·HALO, 1203-5 VEST MEDIUM, COOLMAX LINER, 1211-1...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327359732·2.0MP LEFORT I PLATE,0MM ADVANCEMENT,L
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522112000·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16721312112000·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702421088·ELVAREX 3/THIGH HIGH/SLANT-OPEN TOE-ELEPHANTIAS...
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0112000·Inserter, Universal Inline Fixed
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GILB, MODEL 8010
FDA 510(k)
FDA Class 2
·Dental
INTELLIVUE INFO CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024
RESERVOIR 3M,L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·July 11, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·October 29, 2014
LCP 4.5/5 BROAD CURV 14HO L265 SST
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·July 8, 2013
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2020
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·November 16, 2022
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024