11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Frax 1940 for Nordlys and Frax Pro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131376350·OPN PLAY 1, MINIRITE T 312 2.4G C090
KADANCE 2000
FDA 510(k)
FDA Class 2
·Orthopedic
EZ-IO Intraosseous Vascular Access System
FDA 510(k)
FDA Class 2
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014
NONE
FDA Adverse Event
Product code MBP·August 9, 2011
PUNCTUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
IEXP 55 TI TWISTER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·April 8, 2015
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
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023