40 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0003191·CC/ Creapast IO ochre
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·09010782021040·CC/ Creapast IO ochre
Bard Jejunal Feeding/Gastric Decompression Tube
FDA UDI
Bard Access Systems, Inc.·00801741051630·9 Fr Tether J-Tube
AIM LED
FDA UDI
Burton Medical, LLC·00858480006858·LIGHT HEAD, ALED
Spacelabs Healthcare
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522103827·CABLE,PX,LCF,3SNAP,SHORT,WO/CLIP,RD/YL/GN,ROHS
e-vive II NMES System
FDA UDI
Motive Health, Inc.·00854691008926·e-vive II NMES System with Post-Op Brace; XS, R...
Spacelabs Healthcare
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125249·CABLE,PX,LCF,3SNAP,SHORT,WO/CLIP,RD/YL/GN,ROHS
MONO BENDABLE ONE PIECE IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 24, 2025
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
FDA 510(k)
FDA Class 2
·Cardiovascular
SINGLE SIZE TENDON SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197515399·Laser working element Standard Lock
for 2....
MONO BENDABLE ONE PIECE IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 24, 2025
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·February 18, 2022
ARCHITECT I2000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·November 11, 2014
JEJUNAL FEEDING TUBE 9F
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code KNT·July 16, 2019
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·February 18, 2022
BIOMET TIB BLOCK 6MM 79
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 12, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 18, 2011
RESERVOIR 1.8ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·August 11, 2014