13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
PowerMix™ Dynamic Mixing Tips
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012461·Dental material mixing nozzle, non-sterile
PowerMix™ Dynamic Mixing Tips
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883000615·Dental material mixing nozzle, non-sterile
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033539·Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEu...
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW
FDA 510(k)
FDA Class 2
·General Hospital
2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·April 3, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 24, 2011
APEX MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·April 24, 2008
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code ITX·November 10, 2022
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024