15 results · 20ms · Sources: EU EUDAMED, 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