10 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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Powder Free Nitrile Patient Examination Gloves, Blue Color
FDA 510(k)
FDA Class 1
·General Hospital
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319745175·Millard Double Hook Forceps 6" (15cm), with swi...
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133999·LATERAL,ANGLED TRIAL,0DEG,17X11
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319745182·Millard Double Hook Forceps 4" (10cm), with swi...
SPACELABS SMART DISCLOSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIRTUOSO DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·August 12, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 29, 2014
QUADRA ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
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