14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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