13 results · 24ms · Sources: EU EUDAMED, 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