12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Deep Learning Image Reconstruction
FDA 510(k)
FDA Class 2
·Radiology
LODOX, MODEL BASELINE
FDA 510(k)
FDA Class 2
·Radiology
ILLUMASK ACNE LIGHT THERAPY MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·July 15, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·July 15, 2022
PFC SIGMA C/S NPOR FEM LT SZ4
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 27, 2008
ESSURE
FDA Adverse Event
Other
·BAYER PHARMA AG·Product code HHS·June 22, 2011
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 9, 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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023