23 results · 21ms · Sources: EU EUDAMED, US FDA

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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

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021

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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

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FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021

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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