21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
FDA 510(k)
FDA Class 1
·General Hospital
Ormco
FDA UDI
ORMCO CORPORATION·00889989017458·DISPOSABLE BLADE CAP REMOVER PK/5
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100070·Caddie, Implants and Instruments
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100070·Probe, Steffee Long Str Modular Qtr Sq
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0100010·Caddie, Common Plates and Screws
ACTIVE ARRAY CATHETER, MODEL CS-2000
FDA 510(k)
FDA Class 2
·Radiology
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
BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·May 12, 2021
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 11, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 7, 2008
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 3, 2022
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 3, 2022