9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
FDA 510(k)
FDA Class 1
·General Hospital
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
FDA 510(k)
FDA Class 2
·General Hospital
ATOM TRANSCAPSULE V-707
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 24, 2024
UNKNOWN DEPUY TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSH·October 27, 2008
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 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