17 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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FlightPlan for Liver
FDA 510(k)
FDA Class 2
·Radiology
Zavation
FDA UDI
Zavation LLC·00842166132436·Ti3Z CIF 13mmx15mmx7mm -8 deg
ZAVATION
FDA UDI
Zavation LLC·00842166104525·CIF 13x15, 8 deg, -07
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522108070·
Stainless Steel
FDA UDI
Seaspine Orthopedics Corporation·10889981028398·Down Angled Blade Hook Medium. The Stainless St...
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981027728·Down Angled Blade Hook-Med. The Coral Spinal Sy...
MIGHTY BLISS ELECTRIC HEATING PAD
FDA Adverse Event
Injury
·WHELE LLC.·Product code IRT·January 25, 2023
MUSCLE STIMULATOR SA-100
FDA 510(k)
FDA Class 2
·Physical Medicine
ABG II MONOLITHIC HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD PRECISIONGLIDE¿ 18 G X 1-1/2" HYPODERMIC NEEDLES
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·January 18, 2022
PULSAR MAX II
FDA Adverse Event
Death
·Product code DXY·October 23, 2008
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·August 12, 2011
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 8, 2013
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024
Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.
FDA Recall
Terminated
·Maquet Cardiovascular·Product code DWF·May 19, 2009
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 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