Panels › General, Plastic Surgery › Product code GDC · Class 1
Table, Operating-Room, Electrical
Regulation 878.4960
0510(k)s in 12 months (18 all time)
1recalls in 12 months (27 all time)
2recalls that name a 510(k)
Top companies in GDC
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corporation | 0 | 13 |
| Skytron, Div. the Kmw Group, Inc. | 4 | 1 |
| STERIS Corporation | 1 | 4 |
| Berchtold Corp. | 0 | 3 |
| Stierlen-Maquet AG | 3 | 0 |
| Mdt Corp., Inc. | 2 | 0 |
| Mizuho America, Inc. | 0 | 2 |
| Mizuho OSI | 0 | 2 |
| Skytron, LLC | 0 | 2 |
| Allen Medical Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Baxter Healthcare Corporation Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables Open, Classified |
GDC | None listed |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter TruSystem 7500, Product Code 4091000 Open, Classified |
GDC | None listed |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 Open, Classified |
GDC | None listed |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 Open, Classified |
GDC | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating table TruSystem 7000 U (MB), Product codes:
a) REF 1604786;
b) REF 1604788;
c) REF 1723633 Open, Classified |
GDC | None listed |
| Aug 6, 2024 | Baxter Healthcare Corporation Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 Open, Classified |
GDC | None listed |
| Aug 28, 2023 | Skytron, LLC GS70H Salus Surgical Table, Product Code 18-071-70 Open, Classified |
GDC | None listed |
| Aug 28, 2023 | Skytron, LLC GS70 Salus Surgical Table, Product Code 18-070-70 Open, Classified |
GDC | None listed |
| Jul 7, 2023 | Baxter Healthcare Corporation Allen Advance Chest Support with Pad Open, Classified |
GDC | None listed |
| Nov 3, 2022 | Baxter Healthcare Corporation Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures. Terminated |
GDC | None listed |
| Nov 3, 2022 | Baxter Healthcare Corporation Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position. Terminated |
GDC | None listed |
| Nov 3, 2022 | Baxter Healthcare Corporation Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures. Terminated |
GDC | None listed |
| Nov 3, 2022 | Baxter Healthcare Corporation Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures. Terminated |
GDC | None listed |
| Nov 3, 2022 | Baxter Healthcare Corporation C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001, Terminated |
GDC | None listed |
| Nov 3, 2022 | Baxter Healthcare Corporation Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table Terminated |
GDC | None listed |
| Feb 8, 2021 | Mizuho OSI Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations. Open, Classified |
GDC | None listed |
| Sep 11, 2019 | Mizuho America, Inc. Microsurgical Operating Room Tables;7300BX (18-351-70). Open, Classified |
GDC | None listed |
| Sep 11, 2019 | Mizuho America, Inc. Microsurgical Operating Room Tables;7300B (18-350-70); Open, Classified |
GDC | None listed |
| May 31, 2016 | Skytron, Div. The KMW Group, Inc EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide
General Purpose Surgical Table
Skytron EZ Slide Operating Table
General Purpose Surgical Table Terminated |
GDC | None listed |
| Feb 9, 2016 | Mizuho OSI Mizuho OSI Trios, Table Base;
Voltage: 100-240V ~ 50/60 Hz
Amps: 5,0-5.0A;
Model 7803 and 7803AP
Orthopaedic:
Operating room tablebase - an electronically powered mobile operating table is created, d Terminated |
GDC | None listed |
| Nov 7, 2014 | Steris Corporation The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. Terminated |
GDC | K090136 |
| Sep 9, 2013 | Berchtold Corp. OPERON D850 Surgical Table
Product Usage: Surgical Table Terminated |
GDC | None listed |
| Jun 6, 2013 | Berchtold Corp. Hand Controls for Operon D750, D752, D760, D820 and D850
The hand controls are used to operate OPERON surgical tables Terminated |
GDC | None listed |
| Sep 20, 2012 | Steris Corporation STERIS 5085 and 5085 SRT Surgical Tables,
Product Usage:
The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It Terminated |
GDC | K090136 |
| Jul 7, 2009 | Steris Corp ASC2000 Ambulatory Surgical Table. Model #MTS110003.
The device is used to provide complete and flexible positioning for surgical procedures. Terminated |
GDC | None listed |
| Apr 27, 2009 | Berchtold Corp. Operon Electrical Operating Room Table.
The device is used as an electrical operating room table. Terminated |
GDC | None listed |
| Feb 23, 2007 | Steris Corporation Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450 Terminated |
GDC | None listed |
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