12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111177552·TISSUE FORCEP 2X3 8"
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARIATELE TELEMETRY TRANSMITTER (96281)
FDA 510(k)
FDA Class 2
·Cardiovascular
AZUR VASCULAR PLUG 8
FDA Adverse Event
Injury
·MICROVENTION, INC.·Product code KRD·March 29, 2022
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 27, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 26, 2013
UNICEL DXC 800 PRO SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·October 22, 2014
RGX 3 PEG SER A PATELLA 37MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 31, 2018
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 29, 2023
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019