11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Surgical Gowns
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
KSEA DION-GRACIA SET
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
GUIDANT ABBOTT IRON MAN GUIDE WIRE 300 CM
FDA Adverse Event
Death
·ABBOTT VASCULAR·Product code DQX·October 21, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
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