22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code MRG·April 19, 2018
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377825·Integra® Jarit® Crile-Wood Needle Holder, 7", C...
FREELITE HUMAN LAMBDA FREE KIT
FDA 510(k)
FDA Class 2
·Immunology
LIASYS 450
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZENIX
FDA UDI
Zoll Medical Corporation·00198843003163·ZENIX, EMS, PROFESSIONAL CONFIGURATION
EASYSPINE SCREW, UNKOWN SIZE OR TYPE
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·August 17, 2020
TC CRILE-WOOD NH 7 MATTE
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code MDM·April 20, 2018
TC CRILE-WOOD NH 7 MATTE
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code MDM·April 20, 2018
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 21, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE ROD, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE ROD, UNKNOWN
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code NKB·March 24, 2020
EASYSPINE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code NKB·July 9, 2019
K-Wire Sterile Single Trochar .045, Item Number 19108 - 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