21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
FDA 510(k)
FDA Unclassified
·Unknown
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605784·MAQUET ALPHASTAR 1132 5" SOFTCARE
Symmetry Rhoton® Ultra
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140741·Rhoton Ultra Instruments Bipolar Forceps; Bayon...
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331101410·Rhoton Bipolar Bayonet Forceps, round handle, 1...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450382998·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103150·Shaver, Closed, 15mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024106·Paddle Shaver, 15mm
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094035568·ECG, 3-Lead Cable, one piece shielded 10' cable...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094035575·ECG Cable, 3 Attached Snap Leads, AAMI, 12'
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 6, 2023
NA
FDA UDI
STRYKER CORPORATION·07613327052893·Insert, Fundus Grasper
VENTRICULAR ANALYSIS TOOLKIT OPTION
FDA 510(k)
FDA Class 2
·Radiology
ISCREEN VISION SCREENER
FDA 510(k)
FDA Class 2
·Ophthalmic
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 15, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
PELVILACE BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·April 24, 2013
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·May 6, 2011
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020