28 results
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20ms
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Sources: EU EUDAMED, US FDA
cobas CTNG for use on cobas 6800/8800 systems
FDA 510(k)
FDA Class 2
·Microbiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113424·CRESCENT KNIFE BEVEL UP (BX/5)
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113431·CRESCENT KNIFE DOUBLE BEVEL (BX/5)
AKREOS ADAPT ADVANCED OPTICS ASPHERIC LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·October 19, 2012
CEREC VITABLOCKS MK2
FDA 510(k)
FDA Class 2
·Dental
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION STEM COLLAR COUNTERBORE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LXH·October 16, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 4, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·July 2, 2013
2.7MM DRIVER STEM, FOOT
FDA Adverse Event
Malfunction
·OSTEOMED, LLC·Product code LXH·April 1, 2023
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 29, 2024
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020