13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
LEONE SPA
FDA UDI
LEONE SPA·08033707090298·ABUTMENT MULTITECH IMPL 3,3 STRAIGHT
LEONE SPA
FDA UDI
LEONE SPA·08033707090304·ABUTMENT MULTITECH 360°IMPL. 3,3 ANG.15°
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
MINIME NASAL MASK, MODEL P/N 50220
FDA 510(k)
FDA Class 2
·Anesthesiology
CARDIO 7
FDA 510(k)
FDA Class 2
·Cardiovascular
CHARITE ARTIFICIAL DISC, SIZE UNKNOWN
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code MJO·October 27, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·July 8, 2013
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023
LAPIPLASTY 4.0MM FULLY THREADED SCREW
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025
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