22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
CRYO.S
FDA UDI
Greiner Bio - One GmbH·14039943000498·
NexxZr™ T / D-100-14-NT-OM30-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271114112·
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989053555·PEERLESS 2NDMOL 6DEG UL/LR NDX 0TX022
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180519349·LIF Tamp, Straight
NaturaLyte
FDA UDI
Fresenius Medical Care Renal Therapies Group, LLC·00840861101849·NaturaLyte Liquid Acid Concentrate for Bicarbon...
RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CONTOURS LAPIDUS PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FUJIFILM 600 SERIES ENDOSCOPE EC-600WM
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·January 22, 2025
AVANTA FLUID MANAGEMENT FLUID SYSTEM
FDA Adverse Event
Death
·MEDRAD·Product code DXT·December 17, 2013
12MM/130 DEG TI CANN TFNA 170MM - STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·October 18, 2016
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·October 1, 2014
CORAIL2 STD SIZE 12
FDA Adverse Event
Injury
·DEPUY FRANCE SAS - 3003895575·Product code KWA·May 29, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·June 13, 2011
OT VERIOVUE METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 1, 2015
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·January 20, 2021
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020
Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure.
FDA Enforcement
Class I
·Terminated·Fresenius Medical Care Holdings, Inc.·July 4, 2012
Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·March 29, 2012
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025