44 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
FDA Enforcement
Class II
·Ongoing·James Leckey Design Ltd·April 15, 2020
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
FDA Enforcement
Class II
·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A; 5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A; 6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417; 7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580; 8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581; 9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A; 10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583; 11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A; 12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585; 13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A; 14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586; 15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587; 16) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50, Model Number 96-2590; 17) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591; 18) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591A; 19) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50, Model Number 96-2594; 20) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595; 21) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595A; 22) ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25, Model Number 96-2599; 23) ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100, Model Number 96-2659; 24) ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50, Model Number 96-2710; 25) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711; 26) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711A; 27) ECONO STERILE MAYO-HEGAR NH 8" STERILE CS/50, Model Number 96-2712; 28) ECONO STERILE WEBSTER NH FINE 5.25" STER 25, Model Number 96-2740A; 29) ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25, Model Number 96-2741A; 30) ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25, Model Number 96-2742A; 31) ECONO STERILE HALSEY NH SERR TC 5" STER CS25, Model Number 96-2745A; general orthopedic surgery
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
FDA Enforcement
Class I
·Ongoing·National Distribution & Contracting Inc·October 20, 2021
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 Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
FDA Enforcement
Class I
·Ongoing·National Distribution & Contracting Inc·October 20, 2021
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·March 26, 2025
CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)
FDA Enforcement
Class I
·Ongoing·B Braun Medical Inc·June 10, 2026
2 in 1 Trichomonas / Gardnerella Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 1, 2023
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·June 12, 2024
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 11, 2023
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.
FDA Enforcement
Class II
·Ongoing·ConvaTec, Inc·November 2, 2022
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.
FDA Enforcement
Class II
·Ongoing·ConvaTec, Inc·November 2, 2022
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
FDA Enforcement
Class II
·Ongoing·ConvaTec, Inc·November 2, 2022
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
FDA Enforcement
Class II
·Ongoing·SIN SISTEMA DE IMPLANTE NACIONAL S.A·January 22, 2025
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
FDA Enforcement
Class II
·Ongoing·Abbott Molecular, Inc.·November 30, 2022
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
FDA Enforcement
Class II
·Ongoing·B BRAUN MEDICAL INC·October 15, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.
FDA Enforcement
Class II
·Ongoing·B BRAUN MEDICAL INC·October 15, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
FDA Enforcement
Class II
·Ongoing·B BRAUN MEDICAL INC·October 15, 2025