15 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694529·Titanium Base Abutment Internal Hex. NP H3mm No...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659182721·DCP compression plate f. 3.5mm _x000D_...
DCP compression plate f. 3.5mm screws, length 98mm/8 holes
FDA UDI
mahe medical gmbh·EMAH00200700970·DCP compression plate f. 3.5mm
screws...
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
FDA 510(k)
FDA Class 1
·General Hospital
GSI 2000 MIDDLE EAR ANALYZER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022
LIFEPAK® 15 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·June 21, 2024
TI MATRIXMANDIBLE PREFORMED RECON PL/SMALL/RIGHT/2.5MM THK
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JEY·April 22, 2013
*
FDA Adverse Event
Malfunction
·HETTICH INSTRUMENTS·Product code JQC·April 18, 2011
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015