10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MONOPOLY PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327466171·S-DRILL TAP, HEX 65MM, 1.7x3MM SCREW
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450236291·
PAIN CARE 3000
FDA 510(k)
FDA Class 2
·General Hospital
OLYMPUS SPRAY CATHETER PW-6C-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 3, 2013
MATRISTEM WOUND MATRIX
FDA Adverse Event
Injury
·ACELL INC.·Product code KGN·August 21, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 18, 2011
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2025
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