5,528 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
FDA Enforcement
Class II
·Ongoing·Fridababy LLC·February 19, 2020
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·July 10, 2024
Basic Biopsy Tray, Item Number NMBP44L
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 22, 2024
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
FDA Enforcement
Class II
·Ongoing·Thoratec Corp.·December 8, 2021
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Medical convenience kits IHDC30R D AND C PACK
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
FDA Enforcement
Class II
·Ongoing·iRhythm Technologies, Inc.·November 16, 2022
SlideView VS200 slide viewer,
FDA Enforcement
Class II
·Ongoing·EVIDENT SCIENTIFIC INC·August 7, 2024
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 10910620
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 31, 2024
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 6648161
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 31, 2024
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
FDA Enforcement
Class I
·Ongoing·HeartWare Inc·May 20, 2015
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.
FDA Enforcement
Class II
·Ongoing·Smith & Nephew Orthopaedics AG·August 26, 2020
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
FDA Enforcement
Class I
·Ongoing·Heartware·May 3, 2017
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025