23 results
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21ms
·
Sources: EU EUDAMED, US FDA
Sumitomo Proton Therapy System
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024435·B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 150 MM
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973106661·TRIAL 90-SRK-160612 POLY CR 6X12MM
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
FM20
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·June 10, 2013
OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 6, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·September 5, 2008
CONTOUR NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021
Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 h) Poly Component Trial - CR 5x12, REF 90-SRK-160512 i) Poly Component Trial - CR 5x14, REF 90-SRK-160514 j) Poly Component Trial - CR 6x10, REF 90-SRK-160610 k) Poly Component Trial - CR 6x12, REF 90-SRK-160612 l) Poly Component Trial - CR 6x14, REF 90-SRK-160614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·March 29, 2017
11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·March 22, 2019