16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CoreLink Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113997·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1201-1...
N/A
FDA UDI
Smith & Nephew, Inc.·00817470009590·FEMORAL LOCATOR HANDLE
Aveta Pearl Disposable Hysteroscope
FDA UDI
MEDITRINA, INC.·00850006759064·Aveta Pearl Disposable Hysteroscope for use wit...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970799·
AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 30, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 9, 2013
PINN-A SECTOR ACET CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 28, 2018
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·November 18, 2024
UROSKOP Omnia Max. Model Number: 10762473
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019