18 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Miller Enema Air Tip with Retention Cuff
FDA UDI
Bracco Diagnostics Inc.·10815112021198·Non latex Air Retention Tip
Miller Enema Air Tip with Retention Cuff
FDA UDI
Bracco Diagnostics Inc.·10815112020979·Non latex Air Retention Tip
MARYLAND GRASPING FORCEPS INSERT
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896007475·MARYLAND GRASPING FORCEPS DOUBLE-ACTION JAWS FO...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746109225·DB BKT MINI MS UL CEN 022 T+12 A+5 R=0
MARYLAND GRASPING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929012020·MARYLAND GRASPING FORCEPS DOUBLE-ACTION JAWS FO...
Rampart One Lumbar Interbody Fusion Device
FDA UDI
SPINEOLOGY INC.·M7404901202·Rampart One Standard Spacer
Miracle Suction FULL Kit
FDA UDI
DiaDent Group International·08806383524438·Multifunctional Mirror with Suction
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776395339·PSO Lid
WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,
FDA 510(k)
FDA Class 2
·Orthopedic
MI View&GO
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 14, 2020
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 8, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 17, 2010
SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 6, 2019
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023