14 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950026494·LATEX TUBING 1/8"X1/32" AMBER 50' RL NS W/L
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032942·Baltic Denture System BDLoad Sw7 PLSEbm6DFs C1 ...
LP Low Profile
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162091·DB BKT UL MOL 022 T-14 A+5 R=0
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
FDA 510(k)
FDA Class 2
·Cardiovascular
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
FDA 510(k)
FDA Class 2
·Radiology
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·April 9, 2024
IAB: 8 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·April 1, 2013
ATTAIN ABILITY
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·March 29, 2011
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR SWITZERLAND·Product code FGE·April 23, 2008
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024