19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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eFOLDi Navigator Powerchair (STPC-A)
FDA 510(k)
FDA Class 2
·Physical Medicine
MaXcess
FDA UDI
Nuvasive, Inc.·00887517198631·MaXcess 4 Blade, 110mm Electrode Ctr
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704515275·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776365820·Vessel Clamp, curved
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113851·ARBISSER ANTERIOR CHAMBER CANNULA 30GA ANG 7MM
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105337·WESTCOTT TENOTOMY SCISSORS LEFT
TAPERLOC COMPLETE RASP/PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304632417·
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981042028·31x24mm Trial Rasp 10mm 12 deg
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
FDA 510(k)
FDA Class 2
·General Hospital
GALAXY MIS Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
CENTARGO CT INJECTOR
FDA Adverse Event
Injury
·IMAXEON PTY LTD·Product code DXT·August 29, 2025
ENDO CLIP III
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code FZP·July 25, 2018
MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 21, 2008
ATLAS II PLUS HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 11, 2011
TALENT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 23, 2013
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI: (01)00880304475342(17)211128(10)704850 (01)00880304475342(17)220128(10)094500 (01)00880304475342(17)220328(10)856620 (01)00880304475342(17)220528(10)487710 (01)00880304475342(17)220628(10)028860 (01)00880304475342(17)220628(10)028870 (01)00880304475342(17)220628(10)799030 (01)00880304475342(17)220628(10)799070 (01)00880304475342(17)220628(10)929900 (01)00880304532465(17)220628(10)850060 (01)00880304475342(17)220628(10)803010 (01)00880304532465(17)220728(10)026780 (01)00880304475342(17)220828(10)208370 (01)00880304475342(17)220901(10)811210R (01)00880304475342(17)221028(10)960160 (01)00880304532465(17)221028(10)943820 (01)00880304475342(17)240616(10)237420 (01)00880304475342(17)230909(10)500790 (01)00880304475342(17)221128(10)469390 (01)00880304475342(17)221128(10)864610 (01)00880304532465(17)221128(10)234970 (01)00880304475342(17)221204(10)038140 (01)00880304475342(17)221212(10)630530 (01)00880304475342(17)221212(10)508750 (01)00880304475342(17)221212(10)769380 (01)00880304475342(17)221213(10)801090 (01)00880304475342(17)221213(10)831150 (01)00880304475342(17)221217(10)812790 (01)00880304475342(17)221218(10)543530 (01)00880304475342(17)221219(10)630010 (01)00880304532465(17)221228(10)458650 (01)00880304532465(17)221228(10)752440 (01)00880304532465(17)221228(10)786080 (01)00880304475342(17)230103(10)913540 (01)00880304475342(17)230103(10)628460 (01)00880304475342(17)230103(10)250450 (01)00880304475342(17)230104(10)913530 (01)00880304475342(17)230104(10)994010 (01)00880304475342(17)230107(10)591420 (01)00880304475342(17)230107(10)913550 (01)00880304475342(17)230108(10)732010 (01)00880304475342(17)230111(10)913570 (01)00880304475342(17)230111(10)035570 (01)00880304475342(17)230114(10)918370 (01)00880304475342(17)230117(10)042060 (01)00880304475342(17)230118(10)042100 (01)00880304475342(17)230118(10)014090 (01)00880304475342(17)230121(10)014110 (01)00880304475342(17)230124(10)081050 (01)00880304475342(17)230128(10)967360 (01)00880304532465(17)230128(10)014050 (01)00880304475342(17)230129(10)967280 (01)00880304475342(17)230204(10)913560 (01)00880304475342(17)230205(10)460190 (01)00880304475342(17)230205(10)207400 (01)00880304475342(17)230206(10)081040 (01)00880304532465(17)230207(10)014060 (01)00880304475342(17)230207(10)081030 (01)00880304532465(17)230207(10)843610 (01)00880304532465(17)230207(10)319470 (01)00880304475342(17)230207(10)081060 (01)00880304475342(17)230207(10)274520 (01)00880304475342(17)230208(10)165560 (01)00880304532465(17)230208(10)165530 (01)00880304475342(17)230211(10)165570 (01)00880304532465(17)230211(10)207450 (01)00880304532465(17)230211(10)520910 (01)00880304532465(17)230214(10)112280 (01)00880304475342(17)230214(10)460470 (01)00880304532465(17)230214(10)555280 (01)00880304532465(17)230214(10)173830 (01)00880304532465(17)230215(10)014040 (01)00880304532465(17)230215(10)387150 (01)00880304475342(17)230215(10)165550 (01)00880304475342(17)230215(10)207430 (01)00880304475342(17)230215(10)319510 (01)00880304532465(17)230215(10)512310 (01)00880304532465(17)230215(10)124710 (01)00880304532465(17)230215(10)274460 (01)00880304532465(17)230215(10)322260 (01)00880304532465(17)230215(10)562180 (01)00880304532465(17)230215(10)006420 (01)00880304532465(17)230218(10)319480 (01)00880304475342(17)230218(10)433460 (01)00880304532465(17)230219(10)433400 (01)00880304475342(17)230219(10)319500 (01)00880304532465(17)230219(10)487040 (01)00880304532465(17)230219(10)491250 (01)00880304475342(17)230220(10)446680 (01)00880304532465(17)230220(10)433430 (01)00880304532465(17)230221(10)446660 (01)00880304532465(17)230222(10)433380 (01)00880304475342(17)230222(10)594640 (01)00880304532465(17)230225(1
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019