26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772344116·PROTECT.PRO ACTION BACK SUPPORT BLACK M
TRACHSEALTM ADULT ENDOTRACHEAL CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR
FDA UDI
Intersurgical Incorporated·05030267153633·TRACHSEALTM ADULT ENDOTRACHEAL CLOSED SUCTION S...
ELMED
FDA UDI
ELMED INCORPORATED·00842180159136·PROTECTOR SLOOTED SCOPE MOUNTING SLEEVE FOR 2.7...
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393676·Isolation Gown AAMI 2
Xenix Medical Universal Handle
FDA UDI
XENIX MEDICAL LLC·00840493416182·T-Handle, Large Hudson, Fixed, Grey
IMMUNOCARD TOXINS A & B, MODEL 712050
FDA 510(k)
FDA Class 1
·Microbiology
Callaly Tampliner
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CERTAIN¿ GOLD-TITE¿ LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·October 28, 2022
CERTAIN¿ GOLD-TITE¿ LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·October 29, 2022
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·November 10, 2014
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GAG·November 21, 2008
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 22, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·October 25, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020