16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISOLIS Cryoprobe
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780142898·Integra® Jarit® Smith-Petersen Laminectomy Rong...
Oticon
FDA UDI
Sbo Hearing A/S·05714464029167·OTICON MORE 1 MINIRITE T C094
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020621·INTRG WHISP-Z MBT 2BIC HK -17T 0A 018 LR
devemed
FDA UDI
devemed GmbH·04061644020843·Anatomical tweezers, micro
TC, 0.8 mm, angled
F...
rainbow CT
FDA 510(k)
FDA Class 2
·Radiology
VENTLAB BACTERIAL FILTER, MODEL BF100
FDA 510(k)
FDA Class 2
·Anesthesiology
Reicodent
FDA UDI
devemed GmbH·04061644063178·Anatomical tweezers, micro
TC, 0.8 mm, angled
C...
FOUNDATION
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSA·November 7, 2008
UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·September 1, 2011
S3 EX - 3005
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 16, 2013
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 18, 2011
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015