18 results
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23ms
·
Sources: EU EUDAMED, US FDA
ATRICURE CRYO MODULE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...
18PR - First Aid Complete Kit - Poly Red
FDA UDI
Certified Safety Manufacturing, Inc.·00766588120720·18PR - First Aid Complete Kit - Poly Red
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089422364·
VOXAR VC, MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
Widex
FDA UDI
Widex A/S·05706069658187·Widex DREAM D-FS 110 DEMO (Winter silver ) Tele...
Widex
FDA UDI
Widex A/S·05706069657814·Widex UNIQUE U-FM 110 DEMO (Winter silver ) RC ...
AGX
FDA UDI
Widex A/S·05706069669114·Audigy AGXWD-PA (Winter silver ) RC coil
FORCEPS, WAVESIDE GRASPER
FDA Adverse Event
Malfunction
·RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code GEN·May 2, 2013
BLAZER OPEN-IRRIGATED ABLATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SAN JOSE·Product code LPB·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
TUBE-TO-TUBE CLAMP
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·December 29, 2017
CARDIOSAVE HYBRID
FDA Adverse Event
Injury
·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020
TRIMA ACCEL
FDA Adverse Event
Injury
·TERUMO BCT·Product code GKT·February 27, 2024
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·January 16, 2013
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021