16 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
FDA 510(k)
FDA Class 2
·Orthopedic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293432·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049590·Steinmann Pins, Double trocar, 7/64-inch (2.8mm...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771013006·Steinmann Pins, Double trocar, 7/64-inch (2.8mm...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704912404·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484825·Steinmann pin w. double end trocarpoint _x000D_...
Steinmann pin w. double end trocarpoint 2.8mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM714560·Steinmann pin w. double end trocarpoint
2.8mm/...
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613274859·
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613070222·
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTERJECT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
CATH PKGD: BERMAN 5 FR 5 0CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQO·June 30, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 14, 2014
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021