Transducer, Ultrasonic, Diagnostic
Regulation 892.1570
6510(k)s in 12 months (415 all time)
13recalls in 12 months (147 all time)
118recalls that name a 510(k)
Top companies in ITX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2021 | Athena Medical Products Inc LiquaSonic Ultrasound Gel 5L, Model No. 001222 Terminated |
ITX | K955246 |
| Sep 9, 2021 | Athena Medical Products Inc LiquaSonic Ultrasound Gel 250mL, Model No. 001205 Terminated |
ITX | K955246 |
| Sep 7, 2021 | DJO, LLC Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits: Open, Classified |
ITX | K962840 |
| Sep 7, 2021 | DJO, LLC GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description:
2073/ INTELECT RPW 120V, Open, Classified |
ITX | K955246 |
| Aug 27, 2021 | North Coast Medical Inc EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossag Open, Classified |
ITX | K962840 |
| Aug 27, 2021 | North Coast Medical Inc Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel Open, Classified |
ITX | K955246 |
| Aug 25, 2021 | Accelerated Care Plus Corporation Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures. Open, Classified |
ITX | K955246 |
| Aug 24, 2021 | National Distribution & Contracting Inc ECO 85CB Lotion Ultrasound 8.5 oz 24/cs
ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs
ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs
NDC P301008 ProAdvantage Gel Ultrasound Transmissio Open, Classified |
ITX | K955246 |
| Aug 23, 2021 | Aesthetics Systems Usa Inc Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue. Open, Classified |
ITX | K955246 |
| Aug 18, 2021 | Scrip Inc Scrip Creme All Purpose Lotion
Intended for use in acoustic coupling of ultrasound transducer to tissue Open, Classified |
ITX | K962840 |
| Aug 18, 2021 | Scrip Inc Scrip Ultrasound Gel Clear, 5L
Intended for use in acoustic coupling of ultrasound transducer to tissue Open, Classified |
ITX | K955246 |
| Aug 12, 2021 | AMTEC SALES Inc EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion
1) 100, 200 gel Intended for use in acoustic coupling of ultrasound Open, Classified |
ITX | K955246 K961757 +1 |
| Aug 11, 2021 | Red Medical Supplies EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU Open, Classified |
ITX | K961757 |
| Aug 11, 2021 | Red Medical Supplies EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU Open, Classified |
ITX | K955246 |
| Aug 11, 2021 | Red Medical Supplies EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU Open, Classified |
ITX | K955246 |
| Aug 4, 2021 | Mac Medical Supply Co Inc Ultrasound Gel labeled under the following brand names:
MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 20 Open, Classified |
ITX | K955246 |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover
Item ID: 1006664 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, PE, Elastic Bands, 15x244cm-6"x96"
-Ultrasonic Transducer Cover
Item ID: 1006576 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover 6"x48"- Ultrasonic Transducer Cover
Item ID: SH29 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover
Item ID: SH22 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole
Item ID: SH17 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover
Item ID: HS2000HL Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Hays Ultrasound kit
Item ID: H1000SE Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, 6" x 96", PE, w 3 elastic bands-
Ultrasonic Transducer Cover
Item ID: E6443N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover
Item ID: E6360 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Transducer Cover 15x147cm, Kit, VIP Film
w/ Bands & EMM Gel
Item ID: E6359 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover
Item ID: E5322N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover
Item ID: A-AU-1002N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band -
Ultrasonic Transducer Cover
Item ID: A-AU-10- 058N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover
Item ID: A-AU-0980N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands -
Ultrasonic Transducer Cover
Item ID: A-AU- 0853NA Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands
Item ID: A-AU-0852NA Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands-
Ultrasonic Transducer Cover
Item ID: A-AU-0778NA Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover
Bulk Non-sterile
Item ID: A-AU-0776NA Terminated |
ITX | K101689 |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointe Terminated |
ITX | K011314 |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastroint Terminated |
ITX | K011314 |
| Sep 29, 2020 | Verathon, Inc. BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively. Terminated |
ITX | K172356 |
| Jan 31, 2020 | Hitachi Medical Systems America Inc UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Dop Terminated |
ITX | K134016 K142368 +1 |
| Aug 30, 2019 | Philips Ultrasound Inc Transducer S8-3t
UDI (01)00884838067523
REF 989605420183
Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularl Terminated |
ITX | K030455 |
| Aug 30, 2019 | Philips Ultrasound Inc Transducer S8-3t
UDI (01)00884838073524
REF 989605431171
Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fl Terminated |
ITX | K172607 |
| Aug 30, 2019 | Philips Ultrasound Inc Transducer S7-3t
UDI (01)00884838067530
REF 989605439232
Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body Terminated |
ITX | K030455 K043535 |
| Aug 30, 2019 | Philips Ultrasound Inc Transducer S7-3t
UDI (01)00884838061439
REF 989605406772
Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow a Terminated |
ITX | K160807 K162329 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transd Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transdu Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 seri Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use wi Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use wi Terminated |
ITX | K030064 |
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