10 results
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19ms
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Sources: EU EUDAMED, US FDA
Nitrile Examination Glove (Powder free, Blue)
FDA 510(k)
FDA Class 1
·General Hospital
Oticon
FDA UDI
Oticon A/S·05707131376404·OPN PLAY 1, MINIRITE T 312 2.4G C079
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP.
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017