13 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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Prelude Guide Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517629111·CoRoent Ant TLIF Ti, 11x11x40mm 15°
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003423·Luna Opal R Mini .018 Kit 3x3 U
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707185602·AccuFit™ Molar Band UR7 - 40.5
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113355·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...
EXEL INJECTION PLUG WITH CAP
FDA 510(k)
FDA Class 2
·General Hospital
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. SHANGHAI·Product code INI·October 29, 2014
PROFICIENT PHACO NEEDLE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQC·August 8, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 8, 2013
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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.·August 5, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015