42 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REDAPT Modular Acetabular Shell
FDA 510(k)
FDA Class 2
·Orthopedic
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493932986·AVANOS* Single-Shot Epidural Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651932980·
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·June 20, 2019
BOVIE ICON GENERAL PURPOSE RF GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
FDA 510(k)
FDA Class 2
·Cardiovascular
INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·September 11, 2023
ADVANCE PRELOADED INJECTOR
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LIMITED·Product code MSS·October 14, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 21, 2013
MILLENNIUM MLC - 120 (MULTILEAF COLLIMATOR)
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·June 23, 2011
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019
Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019
Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019
Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall
Terminated
·Covidien LLC·Product code GAM·December 18, 2019