260 results · 12ms · Sources: EU EUDAMED, US FDA

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Burlington Medical, Frontal Aprons

FDA Enforcement
Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

Burlington Medical, Vest

FDA Enforcement
Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

Burlington Medical, Kilt

FDA Enforcement
Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

FDA Enforcement
Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957

FDA Enforcement
Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·February 4, 2026

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

FDA Enforcement
Class I ·Ongoing·SML Distribution, LLC·May 11, 2022

Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;

FDA Enforcement
Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO; d. 20mL Oral Syringe Orange NonSterile, Product Code BC-S20EO; e. 35mL Oral Syringe Orange NonSterile, Product Code BC-S35EO; f. 3mL Oral Syringe Orange NonSterile, Product Code BC-S3EO; g. 60mL Oral Syringe Orange NonSterile, Product Code BC-S60EO; h. 6mL Oral Syringe Orange NonSterile, Product Code BC-S6EO

FDA Enforcement
Class III ·Ongoing·Avanos Medical, Inc.·June 19, 2024

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile, Product Code BB-S60EO; h. 6mL Oral Syringe Blue NonSterile, Product Code BB-S6EO;

FDA Enforcement
Class III ·Ongoing·Avanos Medical, Inc.·June 19, 2024

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonSterile, Product Code BA-S60EO; h. 6mL Oral Syringe Amber NonSterile, Product Code BA-S6EO;

FDA Enforcement
Class III ·Ongoing·Avanos Medical, Inc.·June 19, 2024

Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only

FDA Enforcement
Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

FDA Enforcement
Class II ·Ongoing·Cardinal Health 200, LLC·April 8, 2026

Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·June 3, 2026