30 results
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13ms
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Sources: EU EUDAMED, US FDA
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
FDA Recall
Open, Classified
·Stryker Corporation·Product code HBE·June 28, 2023
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012
FDA Recall
Open, Classified
·Stryker Corporation·Product code HBE·September 5, 2024
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)
FDA Recall
Open, Classified
·Folsom Metal Products, Inc.·Product code HAE·October 30, 2023
Centurion STERILE TRACH BRUSH, Product Code 6225ST
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code EPE·February 23, 2024
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
FDA Recall
Open, Classified
·Phasor Health, LLC·Product code HBE·March 21, 2025
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. These burs are sold as single use devices without their own IFU.
FDA Recall
Open, Classified
·Stryker Corporation·Product code HBE·June 28, 2023
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
FDA Recall
Open, Classified
·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026