12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QStat Cartridge
FDA 510(k)
FDA Class 2
·Hematology
Single Use Injection Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DECLIPSESPECT VIEWER
FDA 510(k)
FDA Class 1
·Radiology
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 7, 2014
ASR 300 SPIKED CUP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
LCS COMPLETE REV FEM CEM L LG+
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC·Product code NJL·July 9, 2013
PINNACLE MTL INS NEUT28IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 4, 2014
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·September 4, 2014
ARTICULEZE M 28MM 5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 4, 2014
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI 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