73 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
FDA 510(k)
FDA Class 2
·Hematology
MiniKut
FDA UDI
DENTAL ENGINEERING LABORATORIES, LLC·00850001745758·MiniKut Retreatment Endodontic Files 20/.06, 25...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0620250·6mm H x 20mm W x 25mm L x 0 degrees XLIF
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X06202580·6mm H x 20mm W x 25mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X062025120·6mm H x 20mm W x 25mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L062025120·6mm H x 20mm W x 25mm L XLIF Trial 12 degree Lo...
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
MACROPORE SURGIWRAP (TS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·December 8, 2025
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·August 11, 2025
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·February 28, 2025
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 16, 2013
CORFLO CUBBY DUAL PORT STANDARD BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·June 13, 2008
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 29, 2025
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 14, 2025