15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ImagenSPECT
FDA 510(k)
FDA Class 2
·Radiology
Temptation NOW® A3 8g
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002097·Crown and Bridge Temporary Resin
Temptation NOW® A3 8g
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003906·Crown and Bridge Temporary Resin
LEONE SPA
FDA UDI
LEONE SPA·08033707014218·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 3
Arx
FDA UDI
Life Spine, Inc.·00190837131395·
Arx
FDA UDI
Life Spine, Inc.·00190837124663·
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
FDA 510(k)
FDA Class 2
·Orthopedic
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 18, 2016
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
ELITE VENT MILLENNIUM SYSTEM
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQE·June 22, 2011
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·September 10, 2008
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025