164 results
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Sources: EU EUDAMED, US FDA
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Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·January 11, 2016
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·April 27, 2016
Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article 10448196, and the Leica M844 C19 Surgical Microscope, article 10448197; ceiling mounted surgical microscopes; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland;; The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·February 27, 2012
Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are three cable connection footswitch models : a) MFS11, stock number 10445599, a 6 function footswitch type B with cross pedals; b) MFS12, stock number 10445600, a 12 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; c) MFS18, stock number 10448164, a 16 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·March 29, 2010
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·June 4, 2012
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland·Product code FSO·December 18, 2012
Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FSO·July 14, 2022
Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are two wireless models: a) MFS20, stock number 10448406, a 12 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; b) MFS21, stock number 10448407, a 16 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·March 29, 2010
MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
FDA Recall
Terminated
·Microvision Medical Holding B.V. Meibergdreef 45 Amsterdam Netherlands·Product code FSO·July 21, 2006
Leica Microsystems M220 F12 Microscope Systems
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·November 3, 2021
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland·Product code FSO·December 18, 2012
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
FDA Enforcement
Class I
·Terminated·Tenacore LLC·April 14, 2021
SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.
FDA Recall
Terminated
·SCC Soft Computer·Product code LNX·June 8, 2006
Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.
FDA Recall
Terminated
·Abbott Molecular·Product code MVU·December 22, 2006
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
FDA Recall
Terminated
·ASO, LLC·Product code MGO·July 26, 2013
Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds.
FDA Recall
Terminated
·ASO, LLC·Product code MGO·July 26, 2013
Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
FDA Recall
Terminated
·ASO, LLC·Product code MGO·July 26, 2013
HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.
FDA Recall
Terminated
·ASO, LLC·Product code MGO·July 26, 2013
First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
FDA Recall
Terminated
·ASO LLC·Product code LRR·March 2, 2022
Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds.
FDA Recall
Terminated
·ASO, LLC·Product code MGO·July 26, 2013