14 results · 22ms · Sources: EU EUDAMED, US FDA

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DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320

FDA 510(k)
FDA Class 2 ·Cardiovascular

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·10304040054892·Polycarbonate Crowns

KALORE™

FDA UDI
Gc America Inc.·D0470035981·KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 uniti...

KALORE™

FDA UDI
Gc America Inc.·14548161293327·KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 uniti...

5F GUIDING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION

FDA 510(k)
FDA Class 2 ·Dental

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 20, 2025

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 18, 2013

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·February 11, 2013

ANEURX STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 22, 2011

SILICONE ADVANCED OPTIC-VIOLET SHIELD

FDA Adverse Event
Malfunction ·BAUSCH & LOMB·Product code HQL·February 20, 2008

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

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024