30 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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uMR 570
FDA 510(k)
FDA Class 2
·Radiology
ReLine
FDA UDI
Nuvasive, Inc.·00195377047076·RELINE-O Trial,12mm H Lamina Ang N L-pop
Paradigm Navigated Drill Guide
FDA UDI
Proprio, Inc.·00850042604274·Paradigm Navigated Drill Guide
OsteoMed
FDA UDI
OSTEOMED LLC·00845694010887·Screw Countersink, Manual
OsteoMed
FDA UDI
OSTEOMED LLC·00845694005715·Right Angle Plate Bender
PTS Hose Set - Single (Female Connector)
FDA UDI
Delfi Medical Innovations Inc·M995922000243·PTS Hose Set (Female metal connector) for use w...
Locking Sannulated Blade Plate System
FDA UDI
ORTHOPEDIATRICS CORP.·00841132144220·SILICON T-HANDLE A-O CONNECT
CARIS MINITOME BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TECO DIAGNOSTICS UTI DETECTION STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·May 29, 2025
Viera Portable Breast Ultrasound
FDA UDI
Clarius Mobile Health Corp·07540205000694·
BOA VISION
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code FGB·February 16, 2023
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·August 10, 2011
DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES HOLDING CORPORATION·Product code NQR·October 21, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013
Synergy MSK Ultrasound
FDA UDI
Clarius Mobile Health Corp·07540205000410·
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 6, 2021
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020