19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLOW 90? Wand
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANATOMIC PEEK CERVICAL FUSION SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994366436·IMPLANT 4240964 ANATOMIC C 16X14X 9MM
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
FDA UDI
NANOVIS SPINE, LLC·00814216028167·ANATOMIC PEEK w/ Nano 16 x 14 x 9 x 4.6°
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000856953·IMPLANT 6240964 ANATOMIC 16X14X9MM
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994305176·IMPLANT 6240964 ANATOMIC 16X14X9MM
CALCULASE II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 25, 2008
HUMAPEN MEMOIR
FDA Adverse Event
Malfunction
·ELI LILLY AND COMPANY·Product code NSC·September 9, 2011
TOTAL CARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·July 17, 2013
5.5 EXP VERSE SCREW 6.0 X 40
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNI·September 16, 2020
5.5 EXP VERSE SCREW 6.0 X 45
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·September 15, 2020
5.5 EXP VERSE SCREW 6.0 X 45
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNI·September 15, 2020
5.5 EXP VERSE SCREW 6.0 X 45
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNI·September 16, 2020
5.5 EXP VERSE SCREW 6.0 X 45
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNI·September 15, 2020
5.5 EXP VERSE SCREW 6.0 X 45
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNI·September 16, 2020
5.5 EXP VERSE SCREW 6.0 X 40
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNI·September 16, 2020
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014