21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single Use Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
M-TWO INSTRUMENT
FDA UDI
SWEDEN & MARTINA SPA·D7700457593·M-TWO INSTRUMENT 20/.06 25 MM, 6 PCS
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604246·MOSS Ti Rod, Ø5.5x65mm, straight
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869621298·MOSS VRS Ti rod, Ø5.5x65mm, straight
TenoTac Soft Tissue Fixation System
FDA UDI
Paragon 28, Inc.·00889795053572·TenoTac Male, 6 x 2.2 x 6.5mm
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TenoTac Soft Tissue Fixation System
FDA UDI
Paragon 28, Inc.·00889795057136·TenoTac Sterile Kit 2nd, 3rd, 4th Digit BOM (di...
TenoTac Soft Tissue Fixation System
FDA UDI
Paragon 28, Inc.·00889795057150·TenoTac Male Implant ø6mm x 2.2mm x 6.5mm Long ...
TenoTac Soft Tissue Fixation System
FDA UDI
Paragon 28, Inc.·00889795114525·STERILE-Female Implant, Short
NA
FDA UDI
Zimmer, Inc.·00889024187733·
NA
FDA UDI
Zimmer, Inc.·00889024187757·
NA
FDA UDI
Zimmer, Inc.·00889024187719·
NA
FDA UDI
Zimmer, Inc.·00889024187740·
NA
FDA UDI
Zimmer, Inc.·00889024187726·
BD NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 25, 2024
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·October 31, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 12, 2011
ATLAS PLUS VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024