102 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209103645·
IPLAN RT IMAGE
FDA 510(k)
FDA Class 2
·Radiology
SPIROL EPIDURAL CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
M2A TPR HI CARBON 37/28MM LNR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 8, 2014
PROMUS ELEMENT ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 23, 2012
ENDOSCOPE
FDA Adverse Event
Injury
·OLYMPUS·Product code FDS·August 9, 2010
Surgical Suture Kit
FDA Recall
Open, Classified
·Stradis Healthcare·Product code MCZ·April 22, 2022
XERF EFFECTOR 60. Electrosurgical unit.
FDA Recall
Open, Classified
·Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of)·Product code GEI·September 4, 2025
LUNA Chest, Model No. LU4006
FDA Recall
Terminated
·Novadaq Technologies, Inc.
13155 Delf Place
Richmond Canada British Columbia·Product code IZI·November 4, 2014
Non-sterile drape
FDA Recall
Terminated
·Novadaq Technologies, Inc.
13155 Delf Place
Richmond Canada British Columbia·Product code IZI·November 4, 2014
Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·August 28, 2009
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016A -- Lot #: 121808-20. Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010
Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0009 -- Lot # 052709-01 Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014 -- Lot # 042209-03. Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010
Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ESE1651 -- Lot # 03059-03 Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016 -- Lot #: 030608-01 and 121808-19. Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013M -- Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014AM -- Lot # 050409-05, 050609-05. Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016AM -- Lot #: 062408-08, 062509-01. Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Recall
Terminated
·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010