223 results
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6ms
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Sources: EU EUDAMED, US FDA
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
FDA Enforcement
Class II
·Ongoing·ASO LLC·August 24, 2022
WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)
FDA Enforcement
Class II
·Ongoing·ASO LLC·May 10, 2023
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
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
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·August 30, 2023
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
FDA Enforcement
Class II
·Ongoing·Radiometer Medical ApS·June 23, 2021
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
FDA Enforcement
Class II
·Ongoing·Radiometer Medical ApS·June 23, 2021
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·November 18, 2020
BEAR Implant. Model Number: 1000.
FDA Enforcement
Class II
·Ongoing·Miach Orthopaedics·February 4, 2026
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
FDA Enforcement
Class II
·Ongoing·Implant Resource Inc·October 27, 2021
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·March 27, 2024
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·March 27, 2024
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·March 27, 2024
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·February 11, 2026