7 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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Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 30, 2014
BIOFINITY
FDA Adverse Event
Injury
·COOPERVISION MANUFACTURING, LTD.·Product code LPM·May 10, 2013
ADVIA CENTAUR
FDA Adverse Event
Injury
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 16, 2011
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