10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
FDA 510(k)
FDA Class 2
·Orthopedic
TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
FDA 510(k)
FDA Class 2
·Orthopedic
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
FDA 510(k)
FDA Class 2
·Orthopedic
HEMOSPHERE FORESIGHT MODULE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MUD·February 26, 2026
UNKNOWN DEPUY GLENOID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSD·October 27, 2008
POLIDENT TABLETS (FORMULATION UNKNOWN)
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code EFT·August 1, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM 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