15 results · 25ms · Sources: EU EUDAMED, US FDA

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Riptide Aspiration System (Riptide Large Bore Aspiration System)

FDA 510(k)
FDA Class 2 ·Cardiovascular

OsteoMed

FDA UDI
OSTEOMED LLC·00845694053709·SmartFlex SPRING NC - 8.5N

CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1

FDA 510(k)
FDA Class 2 ·General Hospital

TOSHIBA 1.5T EXTRA LARGE KNEE COIL

FDA 510(k)
FDA Class 2 ·Radiology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 16, 2021

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 8, 2022

CONNECSCR F/DHS/DCS-WRENCH NO. 338.300

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWB·June 21, 2013

ARCHITECT CA 125 II

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code LTK·October 3, 2008

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE ? SHERBROOKE·Product code FPA·July 28, 2011

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 14, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 14, 2021

Niobe ES System, Models 001-006000-1 and 001-006100-1

FDA Enforcement
Class II ·Terminated·Stereotaxis Inc·November 18, 2020

Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

FDA Enforcement
Class II ·Ongoing·Getinge Usa Sales Inc·October 11, 2023

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020