13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Dental CT Scanner AXR
FDA 510(k)
FDA Class 2
·Radiology
Compressor Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357238163·
DURALOC
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295107002·DURALOC SCREW-IN TRIAL LINER 32mm ID 56mm OD NE...
DIGITAL ELECTROCARDIOGRAPHS
FDA 510(k)
FDA Class 2
·Cardiovascular
CANON FULL AUTO TONOMETER TX-F
FDA 510(k)
FDA Class 2
·Ophthalmic
Chord-X Premeasured Loops and Suture System
FDA UDI
ON-X LIFE TECHNOLOGIES, INC.·00813570020176·Artificial chordal replacement prosthesis
Chord-X Premeasured Loops and Suture System
FDA UDI
ON-X LIFE TECHNOLOGIES, INC.·00813570020077·Artificial chordal replacement prosthesis
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 12, 2013
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026