28 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Enlight 2100
FDA 510(k)
FDA Class 2
·Anesthesiology
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551111573·HALO, 1203-5 VEST SMALL, COOLMAX LINER, 1211-1 ...
CORTAC®
FDA UDI
PMT CORPORATION·00650551065548·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 35 CO...
CORTAC®
FDA UDI
PMT CORPORATION·00650551065562·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 35 CO...
CORTAC®
FDA UDI
PMT CORPORATION·00650551065524·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 35 CO...
CORTAC®
FDA UDI
PMT CORPORATION·00650551065500·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 35 CO...
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
FDA 510(k)
FDA Class 2
·Orthopedic
GSI AUDERA
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CORTAC®
FDA UDI
PMT CORPORATION·00650551090113·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 35 CO...
CORTAC®
FDA UDI
PMT CORPORATION·00650551090076·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 35 CO...
CORTAC®
FDA UDI
PMT CORPORATION·00650551090090·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 35 CO...
CORTAC®
FDA UDI
PMT CORPORATION·00650551090137·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 35 CO...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2016
NOVUM IQ
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 24, 2008
SYMPHONY
FDA Adverse Event
Malfunction
·SORIN CRM·Product code NVZ·August 8, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024