132 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
S4 Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 6, 2024
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 8, 2006
SMALL BATTERY DRIVE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 7, 2013
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 4, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2014
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
FDA Enforcement
Class II
·Terminated·Vidacare Corporation·June 24, 2015
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·February 15, 2023
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·March 14, 2023
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 18, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 24 FR.
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 27, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 25, 2025
RESECTION SHEATH, 24 FR.
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·April 14, 2023
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 8, 2024