20 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Saige-Dx
FDA 510(k)
FDA Class 2
·Radiology
KeySplint Soft for EnvisionTEC
FDA UDI
Keystone Industries·H66842201051·KeySplint Soft for EnvisionTEC 1 kg
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481125409·LOCATOR R-Tx Attachment System, 3.5mm AnyRidge ...
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
FDA UDI
Paonan Biotech Co.,Ltd.·04719878786997·T2 Cannulated Tap 5.5 mm
Ormco
FDA UDI
ORMCO CORPORATION·00889989044348·CROWN-PERM LR 5 1ST MOLAR SST PK/5
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481125461·LOCATOR F-Tx Abutment for Anyridge Internal Con...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112748·BARRON VACUUM PUNCH 7.25MM
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613252250044·Bone Screws, MP, Cross-Pin
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2025
TENS & PMS Unit
FDA 510(k)
FDA Class 2
·Neurology
OsteoMed ExtremiFix Mini & Small System Tray
FDA 510(k)
FDA Class 2
·General Hospital
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·October 31, 2008
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 12, 2011
CURRENT PLUS VR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
ARCHITECT CA 125 II
FDA Adverse Event
Injury
·ABBOTT LABORATORIES·Product code LTK·September 30, 2009
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 3, 2020
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 MM Product Usage: Knee prosthesis
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 3, 2020
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018