51 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
FDA Enforcement
Class I
·Ongoing·National Distribution & Contracting Inc·October 20, 2021
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
FDA Enforcement
Class II
·Ongoing·ASO, LLC·December 12, 2018
3 in 1 STI Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
2 in 1 Trichomonas / Gardnerella Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
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
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
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
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 9, 2025
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 9, 2025
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 9, 2025
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
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
PERIFIX FX Continuous Epidural Anesthesia Tray with 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: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. 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. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.
FDA Enforcement
Class II
·Ongoing·B BRAUN MEDICAL INC·October 15, 2025
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