Panels › General, Plastic Surgery › Product code FSO · Class 1
Microscope, Surgical, General & Plastic Surgery
Regulation 878.4700
0510(k)s in 12 months (15 all time)
0recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in FSO
| Company | 510(k)s | Recalls |
|---|---|---|
| Leica Microsystems, Inc. | 0 | 10 |
| Jedmed Instrument Co. | 4 | 0 |
| Aesculap Implant Systems LLC | 0 | 2 |
| Kelleher Corp. | 2 | 0 |
| Leica Microsystems (Schweiz) Ag | 0 | 2 |
| Moeller Microsurgical, Inc. | 2 | 0 |
| Aesculap Inc | 0 | 1 |
| Appasamy Associates (U.S.A.), Inc. | 1 | 0 |
| Carl Zeiss, Inc. | 1 | 0 |
| Carl Zeiss Suzhou Co., Ltd. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2024 | Aesculap Inc Aeos Robotic Digital Microscope, Product Code: PV010 Open, Classified |
FSO | None listed |
| Oct 26, 2023 | Carl Zeiss Suzhou Co., Ltd. OPMI LUMERA 300, REF 6137 Open, Classified |
FSO | None listed |
| Sep 29, 2022 | Leica Microsystems, Inc. Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950 Open, Classified |
FSO | None listed |
| Sep 29, 2022 | Leica Microsystems, Inc. Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 Open, Classified |
FSO | None listed |
| Sep 29, 2022 | Leica Microsystems, Inc. Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 Open, Classified |
FSO | None listed |
| Sep 29, 2022 | Leica Microsystems, Inc. Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 Open, Classified |
FSO | None listed |
| Jul 14, 2022 | Aesculap Implant Systems LLC Aeos Robotic Digital Microscope with software versions 2.7 or earlier
Article Number: PV010 Terminated |
FSO | None listed |
| Nov 3, 2021 | Leica Microsystems, Inc. Leica Microsystems M220 F12 Microscope Systems Terminated |
FSO | None listed |
| Feb 19, 2021 | Aesculap Implant Systems LLC Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 Completed |
FSO | None listed |
| Apr 15, 2016 | Leica Microsystems, Inc. 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 Terminated |
FSO | None listed |
| Sep 10, 2013 | Leica Microsystems (Schweiz) Ag 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 medica Terminated |
FSO | None listed |
| Sep 10, 2013 | Leica Microsystems (Schweiz) Ag 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 medica Terminated |
FSO | None listed |
| Jul 20, 2012 | Leica Microsystems, Inc. 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 Terminated |
FSO | None listed |
| Mar 21, 2012 | Leica Microsystems, Inc. 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 Microsc Terminated |
FSO | None listed |
| May 20, 2010 | Leica Microsystems, Inc. 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 funct Terminated |
FSO | None listed |
| May 20, 2010 | Leica Microsystems, Inc. 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 1044559 Terminated |
FSO | None listed |
| Aug 23, 2006 | Microvision Medical Holding B.V. MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand Terminated |
FSO | None listed |
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