13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARGLE LATEX PENROSE TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)
BIOACTYS
FDA 510(k)
FDA Class 2
·Dental
LDOB OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 9, 2014
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·October 5, 2007
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·October 23, 2012
BD¿ SYRINGE S2
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 12, 2018
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 30, 2018
Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.
FDA Enforcement
Class II
·Terminated·Medical Positioning Inc·August 20, 2014
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022