23 results · 22ms · Sources: EU EUDAMED, 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