28 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIQUIBAND DUAL, MODEL LBD 001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Redicare
FDA UDI
REDICARE LLC·B70901020760·First Aid Kit to aid in administering Cardiopul...
Oticon
FDA UDI
Oticon A/S·05707131164728·CHILI SP9, BTE 13 SP DBL DEMO
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020760·SPIRA®-A Integrated,Trial, 30x42mm, 8° Lordotic...
Femoral Notch Guide 1
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215056339·
COVERIS
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CS1020760·Trial, 12 x 14.5mm, 3° Lordotic, 8mm
VARIANT
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1020760·Trial 30x38mm, 8° Lordotic, 15mm
Modular Awl Shaft 5.5mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215164942·
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 10, 2025
ATRIUM C-QUR OVT MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROWESS PANTHER PROARC, MODEL VERSION 5.0
FDA 510(k)
FDA Class 2
·Radiology
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP.·Product code FRN·April 22, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 19, 2014
RSP SHOULDER
FDA Adverse Event
Malfunction
·ENCORE MEDICAL, L.P.·Product code HWX·April 14, 2011
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·July 1, 2024
SYRINGE 10ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 21, 2021
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·March 9, 2016
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025