19 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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TECHFIT DISRP® System
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776371739·Sauerbruch Rib Rongeur, square bite, double action
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382805·Integra® Jarit® Sauerbruch Rib Rongeur, 11-3/4"...
Oticon
FDA UDI
Sbo Hearing A/S·05714464029686·OTICON MORE 2 MINIRITE T C092
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114278·CHAMBER MAINTAINER 20GA (PK/10)
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540347794·BIPOLAR FORCEPS
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776092962·Sauerbruch Stille Rong,
devemed
FDA UDI
devemed GmbH·04061644030903·Anatomical tweezers, micro
diamond coated | 0.6...
FLAT PANEL DISPLAYS, CDL SERIES
FDA 510(k)
FDA Class 2
·Radiology
DIMENSION EXL WITH LM SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016
3DKNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·November 7, 2008
COULTER® LH 500 INSTRUMENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·September 1, 2011
ECHELON 60 ENDOPATH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 16, 2013
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
FDA Enforcement
Class II
·Ongoing·Busse Hospital Disposables, Inc.·December 7, 2022
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
UNKNOWN KNEE COMPONENT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 7, 2025