18 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197526975·Ragnell (Killner) scissors
18 cm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197036733·Ragnell (Killner) scissors
15 cm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197036726·TC Ragnell Scissor, curved, 12.0cm
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 26, 2023
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970072·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970102·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970089·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970119·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970096·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970355·
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDI·May 20, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 26, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code FPA·June 10, 2011
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021