699 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MESH SORBA FLX OUL 08X12CM SM
FDA Adverse Event
Injury
·DAVOL- DIVISION OF BARD·Product code FTL·November 10, 2012
COBAS® 6800 SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code MZA·October 8, 2025
NEEDLE 20GA 1IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·February 20, 2024
VERTI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code OUL·May 2, 2014
VERITI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code OUL·April 21, 2014
S1000 THERMAL CYCLER CHASSIS
FDA Adverse Event
Malfunction
·BIO-RAD·Product code OUL·July 18, 2016
S1000 AND C1000 (TOUCH) THERMAL CYCLER CHASSIS
FDA Adverse Event
Malfunction
·BIO-RAD·Product code OUL·July 18, 2016
C1000 (TOUCH) THERMAL CYCLER CHASSIS
FDA Adverse Event
Malfunction
·BIO-RAD·Product code OUL·July 18, 2016
S1000 THERMAL CYCLER CHASSIS
FDA Adverse Event
Malfunction
·BIO-RAD·Product code OUL·July 18, 2016
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model Number DYNDH1266; f) BREAST BIOPSY TRAY, Model Number DYNDH1345A; g) ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A; h) BASIC BIOPSY TRAY, Model Number DYNDH1534; i) ULTRASOUND BIOPSY, Model Number DYNDH1542B; j) CABARRUS BIOPSY TRAY, Model Number DYNDH1670; k) BREAST BIOPSY TRAY, Model Number DYNDH1677; l) NORTH PARK BIOPSY TRAY, Model Number DYNDH1748; m) SOFT TISSUE BIOPSY, Model Number DYNDH1750; n) SOFT TISSUE BIOPSY, Model Number DYNDH1750A; o) UL BIOPSY TRAY, Model Number DYNDH1778; p) BREAST BIOPSY KIT, Model Number DYNDH1822; q) ULTRASOUND BIOPSY, Model Number DYNDH1828; r) BIOPSY PACK-LF, Model Number DYNJ0747885G; s) BIOPSY TRAY, Model Number DYNJ34637G; t) IGT BIOPSY PACK-LF, Model Number DYNJ38616A; u) BIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A; v) CORE BIOPSY PACK-LF, Model Number DYNJ42752A; w) BIOPSY TRAY, Model Number DYNJ43076; x) BIOPSY TRAY, Model Number DYNJ43076A; y) BIOPSY PACK, Model Number DYNJ50485; z) ABLATION/DRAINAGE PACK, Model Number DYNJ53658B; aa) BIOPSY RAD CT, Model Number DYNJ59752A; bb) US BREAST BIOPSY PACK, Model Number DYNJ61992B; cc) US BREAST BIOPSY PACK, Model Number DYNJ61992C; dd) BIOPSY TRAY, Model Number DYNJ62690; ee) IR BIOPSY PACK, Model Number DYNJ63688A; ff) IR BIOPSY PACK, Model Number DYNJ63688B; gg) IR BIOPSY PACK, Model Number DYNJ63688C; hh) IR BIOPSY PACK, Model Number DYNJ63688G; ii) IR BIOPSY PACK, Model Number DYNJ63688I; jj) INSERTION PACK, Model Number DYNJ83149; kk) GENERAL BIOPSY PACK, Model Number P365500; ll) RENAL BIOPSY TRAY, Model Number SPEC0168;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OFG·May 18, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model Number DYNDH1266; f) BREAST BIOPSY TRAY, Model Number DYNDH1345A; g) ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A; h) BASIC BIOPSY TRAY, Model Number DYNDH1534; i) ULTRASOUND BIOPSY, Model Number DYNDH1542B; j) CABARRUS BIOPSY TRAY, Model Number DYNDH1670; k) BREAST BIOPSY TRAY, Model Number DYNDH1677; l) NORTH PARK BIOPSY TRAY, Model Number DYNDH1748; m) SOFT TISSUE BIOPSY, Model Number DYNDH1750; n) SOFT TISSUE BIOPSY, Model Number DYNDH1750A; o) UL BIOPSY TRAY, Model Number DYNDH1778; p) BREAST BIOPSY KIT, Model Number DYNDH1822; q) ULTRASOUND BIOPSY, Model Number DYNDH1828; r) BIOPSY PACK-LF, Model Number DYNJ0747885G; s) BIOPSY TRAY, Model Number DYNJ34637G; t) IGT BIOPSY PACK-LF, Model Number DYNJ38616A; u) BIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A; v) CORE BIOPSY PACK-LF, Model Number DYNJ42752A; w) BIOPSY TRAY, Model Number DYNJ43076; x) BIOPSY TRAY, Model Number DYNJ43076A; y) BIOPSY PACK, Model Number DYNJ50485; z) ABLATION/DRAINAGE PACK, Model Number DYNJ53658B; aa) BIOPSY RAD CT, Model Number DYNJ59752A; bb) US BREAST BIOPSY PACK, Model Number DYNJ61992B; cc) US BREAST BIOPSY PACK, Model Number DYNJ61992C; dd) BIOPSY TRAY, Model Number DYNJ62690; ee) IR BIOPSY PACK, Model Number DYNJ63688A; ff) IR BIOPSY PACK, Model Number DYNJ63688B; gg) IR BIOPSY PACK, Model Number DYNJ63688C; hh) IR BIOPSY PACK, Model Number DYNJ63688G; ii) IR BIOPSY PACK, Model Number DYNJ63688I; jj) INSERTION PACK, Model Number DYNJ83149; kk) GENERAL BIOPSY PACK, Model Number P365500; ll) RENAL BIOPSY TRAY, Model Number SPEC0168;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Thermocycler, Generic
FDA classification
FDA Class 1
·Thermocycler, Generic
IUL SA
FDA registration
IUL SA·2 products·🇪🇸 Spain
Noul Co., Ltd.
FDA registration
Noul Co., Ltd.·6 products·🇰🇷 South Korea
BOULE MEDICAL AB
FDA registration
BOULE MEDICAL AB·5 products·🇸🇪 Sweden
iPeak® reader 4,3" Lateral Flow Reader
FDA UDI
IUL SA·08437022431482·The iPeak® reader 4,3” Lateral Flow Reader (SW ...
BOUGIE A BOULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Swelab Lumi-D Diluent
FDA UDI
Boule Medical AB·07350040796429·The reagents are accessories intended to be use...
Boule EasyCleaner
FDA UDI
Boule Medical AB·07350040791417·Boule EasyCleaner is an accessory intended for ...
IntiMD 8.5 fl oz Water Based Bottle
FDA UDI
Oui Lab, Inc.·00850013300006·IntiMD 8.5 fl oz Water Based Bottle