18 results · 23ms · Sources: EU EUDAMED, US FDA

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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