20 results
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22ms
·
Sources: EU EUDAMED, US FDA
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776092771·Titanium Micro Clamp
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159008791·Micro Clamp
QUASAR
FDA UDI
Modus Medical Devices Inc·G34350036160·MRI4D – Hollow imaging cuboid with isocenter, s...
Temp Esthetic
FDA UDI
Harvest Dental Products, LLC·D87010036161·Temp Esthetic Disc, 98.5 X 16mm, Shade A1
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450174913·
Baby Gorilla®/Gorilla® Plating System
FDA UDI
Paragon 28, Inc.·00889795053350·Drill, 3.6 x 160mm, Solid, Measuring, Long, AO
Paragon 28
FDA UDI
Provision·B504OMP9910036160·
QUASAR
FDA UDI
Modus Medical Devices Inc·G34350036160010·MRI4D – Hollow imaging cuboid with stem and base
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
FDA 510(k)
FDA Class 2
·General Hospital
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
FDA 510(k)
FDA Class 2
·Orthopedic
CADD-PRIZM VIP SYSTEM
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code MEA·December 21, 2018
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·April 10, 2026
MATRIX DISTRACTOR RACK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·February 28, 2013
SHILEY DISPOSABLE CANNULA LOW PRESSURE
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·February 23, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·February 20, 2008
LIGHTSHEER EC
FDA Adverse Event
Injury
·RH USA, INC.·Product code GEX·August 28, 2012
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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