4,140 results
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50ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNIVERSAL 2.7MM LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·March 24, 2017
ZIMMER PERIARTICULAR DISTAL LATERAL FIBULAR PLATE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·November 23, 2016
Facebow
FDA classification
FDA Class 1
·Facebow
KCI Manufacturing
FDA registration
KCI Manufacturing·3 products·🇮🇪 Ireland
VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·April 24, 2019
KCI USA, INC.
FDA registration
KCI USA, INC.·3 products·🇺🇸 United States
KCI USA, INC.
FDA registration
KCI USA, INC.·3 products·🇺🇸 United States
BY ACRE APS
FDA registration
BY ACRE APS·3 products·🇩🇰 Denmark
KCI POLYMEDICS BV
FDA registration
KCI POLYMEDICS BV·1 product·🇧🇪 Belgium
VOLTA
FDA UDI
BIOTRONIK SE & Co. KG·04035479143374·
VOLTA
FDA UDI
BIOTRONIK SE & Co. KG·04035479143381·
VOLTA
FDA UDI
BIOTRONIK SE & Co. KG·04035479143367·
ACIF Interbody System Instruments
FDA UDI
Tyber Medical, LLC·M6950CR0001210·Cervical Inserter with Impaction Cap
AFINION ACR AND ACR CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAM·March 12, 2019
KAR BOW INDUSTRIES CO., LTD.
FDA registration
KAR BOW INDUSTRIES CO., LTD.·1 product·🇨🇳 China
VOLTA
FDA UDI
BIOTRONIK SE & Co. KG·04035479143398·
SUPRAMID EXTRA
FDA UDI
S JACKSON INC·00816848020014·Straight Taper Point (19mm), USP 4-0 SUPRAMID E...
VOLTA
FDA UDI
BIOTRONIK SE & Co. KG·04035479143428·
SUPRAMID EXTRA
FDA UDI
S JACKSON INC·00816848020007·Straight Taper Point (19mm), USP 3-0 SUPRAMID E...