16 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AEQUALIS FX2
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637475·CoRoent Ant TLIF PEEK, 14x11x34mm 15°
Precise
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657008501·Straight Dissecting Forcep, 5mm, 45cm, Standard...
Precise
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657008518·Straight Dissecting Forcep with Ratchet, 5mm, 45cm
Precise
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657075565·Precise Straight Dissecting Forcep, 5mm, 45cm I...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046541·PrimaLIF LLIF PEEK Implant, 13mm X 26mm X 45mm,...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523181308·Ø4.5mm X 14mm, Fixed Angle Screw, Self-Drilling...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523181315·Ø4.5mm X 16mm, Fixed Angle Screw, Self-Drilling...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523181322·Ø4.5mm X 18mm, Fixed Angle Screw, Self-Drilling...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523181292·Ø4.5mm X 12mm, Fixed Angle Screw, Self-Drilling...
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
LIFEPAK 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·June 1, 2011
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022