10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
ANYONETM INTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 7, 2025
UNKNOWN DEPUY TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSH·October 27, 2008
CARESCAPE V100 VITAL SIGNS MONITOR
FDA Adverse Event
Other
·CRITIKON DE MEXICO S. DE R.L. DE C.V.·Product code MHX·June 23, 2011
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·July 3, 2013
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024