32 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRESERVE HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
GUEDEL AIRWAY, SIZE 2, ISO 8
FDA UDI
Intersurgical Incorporated·05030267050659·GUEDEL AIRWAY, SIZE 2, ISO 8
NA
FDA UDI
MEDTRONIC XOMED, INC.·00681490033343·PROSTHESIS 1112080 H/A TOTAL 90 ROUND
ALIF Disc Prep
FDA UDI
Life Spine, Inc.·00190837079918·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809265158691·
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521112080D0·12 x 80 mm Anodized SI Implant Fully Threaded
Alignment Guide
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068721·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809265158721·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809265158707·
Jeil Bone Fixation System
FDA UDI
Jeil Medical Corporation·08806390878029·
Bone Fixation Screw Kit
FDA UDI
Jeil Medical Corporation·08806390852135·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809265158714·
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEPUY RECLAIM REVISION HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873098590·3.5mm Locking Superior Clavicle Plate, 6 Holes,...
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
FDA Enforcement
Class II
·Ongoing·Intersurgical Inc·August 13, 2025
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 7, 2013
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·Product code NBW·June 2, 2011