15 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517564511·CoRoent Ant TLIF PEEK, 12x10x28mm 4°
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197033541·Heymann Knight Nasal Scissor
straig...
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522100673·LDWR,SET,DIN,PNCH,3-LEAD,102CM/40IN,AAMI,1/ST
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522100680·LDWR SET,PINCH,DIN,61CM/ 24 IN,AAMI,3LW/ST, 1/ST
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522100659·LDWR,SET,DIN,PNCH,3-LEAD,46CM/18IN,AAMI,1/ST
LIQUIBAND ULTIMA, LUT 003
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
GOLDEN COMFORTER
FDA Adverse Event
Malfunction
·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·April 22, 2020
ASR XL TAP SLV ADAP 12/14+2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 14, 2008
SAFESHEATH II 9F
FDA Adverse Event
Malfunction
·OSCOR INC.·Product code DYB·August 10, 2022
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