15 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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HARDYDISK LEVOFLOXACIN, 5MCG
FDA 510(k)
FDA Class 2
·Microbiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182222·
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·February 20, 2015
SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 14, 2020
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
FDA 510(k)
FDA Class 2
·Cardiovascular
Span-America
FDA UDI
SPAN-AMERICA MEDICAL SYSTEMS, INC.·H93300266400000·ZIMMER ULNAR PROTECTOR 12PR/CS
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 11, 2018
EXETER. FEMORAL STEM + 2 PMMA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·March 13, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 9, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 26, 2008
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
BD POSIFLUSH¿ SF SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·November 7, 2019
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025