15 results · 27ms · Sources: EU EUDAMED, US FDA

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Light Based Hair Removal Device GP592

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Bernafon

FDA UDI
Sbo Hearing A/S·05714464021581·CORAL 1 FW 4.1

Cooley Ring-Bulldog Clamp 12cm curved

FDA UDI
Geister Medizintechnik GmbH·04057034060834·Cooley Ring-Bulldog Clamp 12cm curved

SacroFuse

FDA UDI
SPINEFRONTIER, INC.·00190361036081·SCREW, SOLID WALL, CANNULATED, Ø8MM X 60MM, SAC...

Flexible Driver

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215058166·

SPINEMED

FDA 510(k)
FDA Class 2 ·Physical Medicine

Reprocessed NRG Transseptal Needle

FDA 510(k)
FDA Class 2 ·Cardiovascular

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 11, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 31, 2011

SOFTCLIX ® LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 16, 2013

UNKNOWN SALINE IMPLANTS

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·March 16, 2023

MAZOR X SYSTEM

FDA Adverse Event
Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

COMP RVRS SHLDR GLNSP STD 36MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·March 14, 2025

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