ClearanceBrief
Panels › Radiology › Product code ITX · Class 2

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)
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Top companies in ITX

DateFirm and productCodeLinked 510(k)
Sep 9, 2021Athena Medical Products Inc
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Terminated
ITXK955246
Sep 9, 2021Athena Medical Products Inc
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Terminated
ITXK955246
Sep 7, 2021DJO, 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
ITXK962840
Sep 7, 2021DJO, 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
ITXK955246
Aug 27, 2021North 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
ITXK962840
Aug 27, 2021North 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
ITXK955246
Aug 25, 2021Accelerated 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
ITXK955246
Aug 24, 2021National 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
ITXK955246
Aug 23, 2021Aesthetics Systems Usa Inc
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Open, Classified
ITXK955246
Aug 18, 2021Scrip Inc
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Open, Classified
ITXK962840
Aug 18, 2021Scrip Inc
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Open, Classified
ITXK955246
Aug 12, 2021AMTEC 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
ITXK955246
K961757 +1
Aug 11, 2021Red Medical Supplies
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Open, Classified
ITXK961757
Aug 11, 2021Red Medical Supplies
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Open, Classified
ITXK955246
Aug 11, 2021Red Medical Supplies
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Open, Classified
ITXK955246
Aug 4, 2021Mac 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
ITXK955246
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Hays Ultrasound kit Item ID: H1000SE
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
Terminated
ITXNone listed
Apr 29, 2021Exact 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
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
Terminated
ITXNone listed
Apr 29, 2021Exact 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
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Terminated
ITXNone listed
Apr 29, 2021Exact Medical Manufacturing, Inc.
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
Terminated
ITXNone listed
Apr 29, 2021Exact 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
ITXK101689
Oct 16, 2020Olympus 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
ITXK011314
Oct 16, 2020Olympus 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
ITXK011314
Sep 29, 2020Verathon, Inc.
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Terminated
ITXK172356
Jan 31, 2020Hitachi 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
ITXK134016
K142368 +1
Aug 30, 2019Philips 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
ITXK030455
Aug 30, 2019Philips 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
ITXK172607
Aug 30, 2019Philips 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
ITXK030455
K043535
Aug 30, 2019Philips 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
ITXK160807
K162329
Nov 2, 2018CIVCO Medical Instruments Co., Inc.
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
Terminated
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO Medical Instruments Co., Inc.
CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
Terminated
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064
Nov 2, 2018CIVCO 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
ITXK030064

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