11 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OsteoMed ExtremiLOCK Wrist Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197031035·Metzenbaum-Fino Scissors Fig. 1
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197381390·CERA-CUT® Metzenbaum Fino Scissors
straig...
MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2
FDA 510(k)
FDA Class 2
·Radiology
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 21, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 7, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
TRUE METRIX AIR
FDA Adverse Event
Injury
·TRIVIDIA HEALTH INC·Product code NBW·September 28, 2022
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024