11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRO-MAT SYSTEM
FDA 510(k)
FDA Class 1
·Hematology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209126118·
Wildlife
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746031632·ELASTICS INTRA-ORAL HEAVY 6.5 OZ 3/16" 1000/BAG
EXTENSION, DUAL 4 CHANNEL 10CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·November 26, 2025
Colli-PeeDx Urine Collection Kit
FDA 510(k)CLAMP, TUBING, LINE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
URISYS 1100
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JIO·June 6, 2014
ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·December 3, 2012
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·September 2, 2010
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015