453 results
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12ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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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 transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
FDA Enforcement
Class I
·Ongoing·AMTEC SALES Inc·September 29, 2021
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U
FDA Enforcement
Class I
·Ongoing·Bolton Medical Inc.·June 3, 2026
Halyard CATH LAB kit. Model Number: SACL75-01.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·May 13, 2026
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·May 13, 2026
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·May 13, 2026
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·May 13, 2026
Halyard CATH LAB kit. Model Number: SACL75AM.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·May 13, 2026
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·May 13, 2026
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·May 13, 2026
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·May 13, 2026
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·January 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·January 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
FDA Enforcement
Class I
·Ongoing·AVID Medical, Inc.·January 14, 2026
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
FDA Enforcement
Class I
·Ongoing·ICU Medical, Inc.·October 29, 2025
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
FDA Enforcement
Class I
·Ongoing·Medical Depot Inc.·May 21, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
FDA Enforcement
Class I
·Ongoing·Avanos Medical, Inc.·April 23, 2025
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Enforcement
Class I
·Ongoing·Conavi Medical Inc.·April 30, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
FDA Enforcement
Class I
·Ongoing·Avanos Medical, Inc.·April 23, 2025
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
FDA Enforcement
Class I
·Ongoing·Avanos Medical, Inc.·April 23, 2025
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
FDA Enforcement
Class I
·Ongoing·Qapel Medical Inc.·April 16, 2025