19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHILIPS MICRODOSE
FDA 510(k)
FDA Class 2
·Radiology
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007928·SOSOFT 30-40 MM HG KNEE HIGH BROCADE SMALL BLAC...
ARGISTAR 598 (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120255·Gold based noble metal
AF811
FDA UDI
Respironics, Inc.·00606959034389·AF811 Mask SE with Headgear, Medium
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584856·Apex Tibial Nail Ø 12 x 255mm
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017121·Hook Scissors 3.5mm 45 degree right
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197033329·Toennis Scissor
18.0 c...
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017114·Hook Scissors 2.7mm 45 degree right
DMP ETCHING GEL
FDA 510(k)
FDA Class 2
·Dental
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GOLDEN COMFORTER
FDA Adverse Event
Malfunction
·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 10, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 14, 2008
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
ENDURO MENISCAL COMPONENT F1 10MM
FDA Adverse Event
Injury
·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016
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