13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
FDA 510(k)
FDA Unclassified
·Unknown
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)
CastleLoc-P Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
R2-MRI ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD LOGIC BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·August 28, 2006
SYRINGE 30ML LL S/C 56
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 2, 2025
SL 1 INTRODUCER UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 10, 2011
RESPONSE EP CATHETER UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·March 10, 2011
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 10, 2011
WEDGE TURNING FRAME
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·September 1, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 11, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 23, 2013
PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014