23 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120663·Guidewire 2.0x230mm Sgl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120656·Guidewire 2.0x230mm Drill Tip
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776302252·JASEN-ZAUFEL RONGEUR 7" 4mm BITE CURVED
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120670·Guide wire, 2.0x230mm Pt.Thrd.
SPACELABS HEALTHCARE CARDIOEXPRESS
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
FDA 510(k)
FDA Class 1
·General Hospital
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 Recall
Terminated
·Zimmer Biomet, Inc.·Product code KWS·August 21, 2019
1-DAY ACUVUE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·November 13, 2008
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 1, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025
FORZA F5
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·February 27, 2023
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024