14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1Derful HS, 1Derful HT
FDA 510(k)
FDA Class 2
·Dental
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026
TITANIUM COMPRESSION ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EASYFIT SILKGEL NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 7, 2021
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026
CB - X II DUAL - ENDED CLEANING BRUSH
FDA Adverse Event
Malfunction
·KIMBERLY CLARK GLOBAL SALES, INC.·Product code KNW·October 24, 2008
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·August 12, 2011
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 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