8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DBB-06 Hemodialysis Delivery System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACQPOINT THERMAJADE MASSAGE TABLE
FDA 510(k)
FDA Class 2
·Physical Medicine
CR-PRO
FDA 510(k)
FDA Class 2
·Radiology
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 8, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 7, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 8, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022