12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
FDA 510(k)
FDA Class 2
·Physical Medicine
Border-Lock® Upper Tray #49
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883007133·Dental impression tray, single-use
Border-Lock® Upper Tray #49
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015875·Dental impression tray, single-use
BIOPRO GO-EZ SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DRILL, AO, STERILE ?4, 2X340MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 10, 2010
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 2, 2008
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 21, 2013
BARDEX I.C.
FDA Adverse Event
Malfunction
·BARD·Product code KOD·July 20, 2011
Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·April 24, 2019
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018