13 results · 22ms · Sources: EU EUDAMED, US FDA

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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