23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ICAM FUNDUS CAMERA
FDA 510(k)
FDA Class 2
·Ophthalmic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613100674·Hank Uterine Dilator, Double Ended, Size 17/18F...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613111472·Hank Uterine Dilator, Double Ended, Size 9/10Fr...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613089535·Hank Uterine Dilator, Double Ended, Size 19/20F...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613087562·Hank Uterine Dilator, Double Ended, Size 13/14F...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613086596·Hank Uterine Dilator, Double Ended, Size 11/12F...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613100087·Hank Uterine Dilator, Double Ended, Size 15/16F...
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
OPT SLEEVE 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 21, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·September 26, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011
K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·August 21, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020