24 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHYSIOFLOW Q-LINK
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003742·Short Left Reconstruction Plate w/Angle
RHEAD
FDA UDI
Stryker GmbH·00886385023274·Extended Stem Broach; Size 2
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180521076·Plunger Tamp, Conical Tip
CS-SERIES-FP
FDA 510(k)
FDA Class 2
·Radiology
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
FDA 510(k)
FDA Class 1
·General Hospital
IntelliCart™
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024466036·
IntelliCart™
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024466005·
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·October 3, 2014
NOVOFINE 6MM (31G)`
FDA Adverse Event
Other
·NOVO NORDISK A/S·Product code FMI·May 21, 2013
RHEUMATOID FACTOR TEST SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code DHR·June 25, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023
DUO FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·March 4, 2019
OSTEOMED
FDA Adverse Event
Malfunction
·OSTEOMED·Product code HRS·February 14, 2020
Artis zee floor MN, Model Number 10094142
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Artis zee floor MN, Model Number 10094142
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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
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 Recall
Open, Classified
·North American Rescue LLC.·Product code LRR·March 27, 2026