24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAM Model 9-10000
FDA 510(k)
FDA Class 2
·Anesthesiology
Calasept®Plus
FDA UDI
Directa AB·17310230000146·
INSERTION GUIDE, EXTENDED TIBIAL NAIL
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665006063·
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481125225·LOCATOR R-Tx Attachment System, 3.5mm, Performa...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776181949·Bruns Curette hollow hdl str oval
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191421·PATELLA CALIPER
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776414931·Bruns Curette 6.75 Hollow Handle Str Oval #000
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702778557·ELVAREX 2/KNEE HIGH/PROFILE-SLANT-CLOSED TOE-EL...
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARROW ECHOGENIC INTRODUCER NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
Widex
FDA UDI
Widex A/S·05706069548587·Widex Link Connector
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2013
PASSPORT
FDA Adverse Event
Other
·DATASCOPE CORP.·Product code DXW·April 4, 2003
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·July 9, 2013
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·July 1, 2022
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 4, 2024
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).
FDA Enforcement
Class I
·Ongoing·North American Rescue LLC.·May 6, 2026