13 results
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51ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REV-MED INC.
FDA registration
REV-MED INC.·1 product·🇰🇷 South Korea
Hilthera 4.0
FDA UDI
REV-MED Inc.·08809326582113·
THERMOCOOL SMARTTOUCH SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·August 28, 2024
QDOT MICRO
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code OAE·August 28, 2024
TI LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code NKG·June 23, 2017
TUTOPATCH BOVINE PERICARDIUM
FDA Adverse Event
Injury
·TUTOGEN MEDICAL GMBH (TMI)·Product code GXQ·July 1, 2025
Recall of Alcohol Pads contained in the following kits distributed by Medtronic: ***REF 1529100***Thermasplint Kit, Small***X5***. ***REF 1529110***Thermasplint Kit, Medium***X5***. ***REF 1529120***Thermasplint Kit, Large***X5***. RECALLED PRODUCT - Front: ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. RECALLED PRODUCT - Back: ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.***
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code EPP·February 21, 2011
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·March 6, 2024
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·October 30, 2024
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·June 26, 2025
An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. Recall of Alcohol Pads contained in the following kits distributed by Medtronic: ***REF 1528116***External Nasal Splint Kit, Small***X5***. ***REF 1528126***External Nasal Splint Kit, Medium***X5***. ***REF 1528136***External Nasal Splint Kit, Large***X5***. RECALLED PRODUCT - Front: ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. RECALLED PRODUCT - Back: ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.*** Each Kit Includes the dorsum pad (splint), an alcohol sponge (prep pad), skin preparation and skin closure tapes (steri-strips).
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code EPP·February 21, 2011
LEAD MODEL 304
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·February 21, 2025
ENDOPATH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC., QUALITY ASSURANCE/MED DEV. DIV.·Product code GCJ·March 12, 1999