110 results
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7ms
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Sources: EU EUDAMED, US FDA
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G; 7) PREOP KIT, Medline kit SKU DYKS1313A; 8) PRE OP KIT, Medline kit SKU DYKS1325A; 9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D; 10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A; 11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B; 12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B; 13) PRE OP KIT, Medline kit SKU DYKS1382A; 14) PRE OP KIT, Medline kit SKU DYKS1416F; 15) PREOP KIT, Medline kit SKU DYKS1448B; 16) PRE-OP KIT, Medline kit SKU DYKS1458F; 17) PRE OP KIT, Medline kit SKU DYKS1467B; 18) PRE OP KIT, Medline kit SKU DYKS1468; 19) PRE-OP, Medline kit SKU DYKS1482A; 20) ADULT PRE OP, Medline kit SKU DYKS1487I; 21) PRE OP ENDO, Medline kit SKU DYKS1489F; 22) PREOP KIT, Medline kit SKU DYKS1507B; 23) PRE OP KIT, Medline kit SKU DYKS1518A; 24) PRE OP KIT, Medline kit SKU DYKS1544F; 25) PREOP, Medline kit SKU DYKS1551B; 26) PREOP, Medline kit SKU DYKS1552B; 27) PREOP, Medline kit SKU DYKS1580; 28) PRE OP KIT, Medline kit SKU DYKS2024A; 29) PRE OP KIT, Medline kit SKU DYKS2056A; 30) PRE-OP KIT, Medline kit SKU DYKS2074; 31) PRE-OP KIT, Medline kit SKU DYKS2074A; 32) PREOP KIT, Medline kit SKU DYKS2076; 33) PRE OP KIT 1, Medline kit SKU DYKS2083; 34) PRE OP KIT, Medline kit SKU DYKS2103.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·January 21, 2026
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
FDA Enforcement
Class II
·Ongoing·Wondfo USA Co Ltd·June 19, 2024
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
FDA Enforcement
Class II
·Ongoing·ConvaTec, Inc·January 22, 2025
MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·November 2, 2022
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
FDA Enforcement
Class II
·Ongoing·Healthmark Industries Co., Inc.·June 11, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·January 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770; 6) SURGERY BAG, Medline kit SKU DYKM1279C; 7) ADMISSION KIT, Medline kit SKU DYKS1179; 8) PRE OP KIT, Medline kit SKU DYKS1192C; 9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B; 10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B; 11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248; 12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249; 13) PRE OP KIT, Medline kit SKU DYKS1274A; 14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324; 15) PRE OP KIT, Medline kit SKU DYKS1376; 16) PTC KIT, Medline kit SKU DYNDH1161A; 17) DR BROWN BODY, Medline kit SKU DYNJ910487.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·January 21, 2026
MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·November 2, 2022
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·November 2, 2022
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·November 2, 2022
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·November 2, 2022
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
FDA Enforcement
Class II
·Ongoing·Healthmark Industries Co., Inc.·June 11, 2025
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·April 29, 2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·April 29, 2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·April 29, 2026
Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·October 11, 2023
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·October 11, 2023
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·October 11, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·October 11, 2023
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·October 11, 2023