14 results · 19ms · Sources: EU EUDAMED, US FDA

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CLINIFLO INCENTIVE SPIROMETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00531461·

TruForm

FDA UDI
Rmo, Inc.·00885797099662·MAX MOLAR BDS PEDO ASST 100

TensCare

FDA UDI
TENSCARE LIMITED·05033435136490·The Nouri Digital Electric Breast Pump is a pow...

TRIFECTA

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730015341·TRIFECTA NiTiTherm Lower 18x25 10 archwires per...

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014

GENYX FLEXIBLE INJECTION NEEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·Product code KDJ·February 28, 2011

COLLEAGUE CX TRIPLE CHANNEL VOLUMTRIC INFUSION PUMP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE PTE. LTD·Product code FRN·February 4, 2008

Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

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