18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LANDMARK REBOA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517298959·CoRoent® XL-XW, 14x26x60mm
NA
FDA UDI
Synthes GmbH·10886982153623·4.5MM CORTEX SCREW 60MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114000·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1201-1...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694020701·FPS 4.0mm x 60mm Standard Screw
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002964·Cervical PEEK, 6°, 14mm W x 12mm D x 6mm H
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075060·FPS 4.0 x 60mm Screw Sterile Qty 2
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002988·Cervical PEEK, 10°, 14mm W x 12mm D x 6mm H
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002971·Cervical PEEK, 0°, 12x14x6
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROAIRE 1000E SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
INVICTUS
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·November 21, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 30, 2014
ETRIO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·August 17, 2011
VALIANT
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 9, 2013
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
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017