Panels › General, Plastic Surgery › Product code JEA · Class 1
Table, Surgical With Orthopedic Accessories, Ac-Powered
Regulation 878.4960
0510(k)s in 12 months (10 all time)
0recalls in 12 months (41 all time)
1recalls that name a 510(k)
Top companies in JEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Trumpf Medical Systems | 0 | 20 |
| Baxter Healthcare Corporation | 0 | 14 |
| Andronic Devices, Ltd. | 4 | 0 |
| Mizuho Orthopedic Systems Inc | 0 | 3 |
| Mizuho OSI | 0 | 2 |
| Orthopedic Systems, Inc. | 2 | 0 |
| Steris Corporation | 0 | 2 |
| M.D. Intl., Inc. | 1 | 0 |
| Mend Technologies, Inc. | 1 | 0 |
| Skytron, Div. the Kmw Group, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 Open, Classified |
JEA | None listed |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 Open, Classified |
JEA | None listed |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 Open, Classified |
JEA | None listed |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter Mobile column TruSystem 7500, Product Code 1717023 Open, Classified |
JEA | None listed |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter Floor mounting column TruSystem 7500, Product Code 1717021 Open, Classified |
JEA | None listed |
| Mar 21, 2025 | Baxter Healthcare Corporation Baxter Stationary column TruSystem 7500, Product Code 1717020 Open, Classified |
JEA | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 Open, Classified |
JEA | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 Open, Classified |
JEA | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083 Open, Classified |
JEA | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 Open, Classified |
JEA | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 Open, Classified |
JEA | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 Open, Classified |
JEA | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 Open, Classified |
JEA | None listed |
| Oct 24, 2024 | Baxter Healthcare Corporation Baxter Operating Table TruSystem 7000, Product code REF 1841046 Open, Classified |
JEA | None listed |
| Jan 21, 2021 | Steris Corporation OT1000 Series Orthopedic Surgical Tables Terminated |
JEA | None listed |
| Oct 14, 2019 | Mizuho OSI Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI
Refurbished Levo Arm Label: LEVO ARM REF 7887-050R
MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head supp Terminated |
JEA | None listed |
| Nov 10, 2016 | Trumpf Medical Systems, Inc. OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798 Terminated |
JEA | None listed |
| Oct 5, 2016 | Trumpf Medical Systems, Inc. Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786
Patient positioning during surgery, ranging from anesthesia induction to actu Terminated |
JEA | None listed |
| Oct 5, 2016 | Trumpf Medical Systems, Inc. Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878
Patient positioning during surgery, ranging from anesthesia induction to actual surgery Terminated |
JEA | None listed |
| Oct 5, 2016 | Trumpf Medical Systems, Inc. Stationary Column TruSystem 7599, Material Number 1717020
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transpo Terminated |
JEA | None listed |
| Oct 5, 2016 | Trumpf Medical Systems, Inc. Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to Terminated |
JEA | None listed |
| May 23, 2016 | Steris Corporation OT1000 Series Orthopedic Surgical Tables Terminated |
JEA | None listed |
| Jan 19, 2016 | Trumpf Medical Systems, Inc. Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems).
The shuttle is intended for the following applications: 1. Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesth Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from ane Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Pat Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anes Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthe Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesi Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from a Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthe Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesth Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery fro Terminated |
JEA | None listed |
| Jan 6, 2015 | Trumpf Medical Systems, Inc. Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915.
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anest Terminated |
JEA | None listed |
| Oct 27, 2014 | Trumpf Medical Systems, Inc. TITAN Operating Room Table
Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the p Terminated |
JEA | None listed |
| Nov 5, 2013 | Trumpf Medical Systems ORBIT PT.
The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process. Terminated |
JEA | None listed |
| Feb 13, 2013 | Mizuho OSI Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar. Terminated |
JEA | None listed |
| Oct 27, 2011 | Mizuho Orthopedic Systems Inc Mizuho OSI Modular Table System;
Product Usage: For use in orthopaedic surgery to provide support to a patient. Terminated |
JEA | K910736 |
| Jan 20, 2011 | Mizuho Orthopedic Systems Inc Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA. Terminated |
JEA | None listed |
| Dec 13, 2007 | Mizuho Orthopedic Systems Inc OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic Surgery Table-- Stand alone single-pedestal AC power or battery operated table, Orthopedic Systems, Inc., Union City, CA Terminated |
JEA | None listed |
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