9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Coda LP Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
AGXO
FDA UDI
Oticon A/S·05707131284068·H100V2, MINIBTE 312 WL 85 STG AGXO
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100189·MCINTYRE SPECULUM CLOSED WIRE
MILO DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
STAINLESS STEEL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·June 6, 2013
HIP HEAD, 10/12 TAPER, 28MM, +0MM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·June 29, 2011
HS ACE 14 CM SCISSOR HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 28, 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