5,514 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 5/8"X50YDS Catalog # GL-241. e. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 11/2"X50YDS Catalog # GL-243
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1"X5YDS STR LF (12/CS) MGM61 Catalog #61-59320. d. DERMA SCIENCES, INC. MediHoney DRESSING, MEDIHONEY GEL STR TU0.5OZ (10/BX 4BX/CS) MGM61 Catalog #DUP31805. e. DERMA SCIENCES, INC DuPad PAD, ABD STR 8X10 (25/BX 8BX/CS) Catalog #DUP87810. f. DERMA SCIENCES, INC Shur-Conform Oil Emulsion non-adhering DRESSING, OIL EMULSION 3"X3"23251-210 DERSCI Catalog #DKC77041
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube & Surgigrip APPLICATOR, SURGITUBE/GRIP METAL SZ3 6" CHLD/ADLT DERSCI Catalog #GL-234.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 100 Tests Model Number: 4487. c. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 50 Tests Model Number: 127-50ER
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
24K Premium Lense, Distributed by Updream Inc.
FDA Enforcement
Class II
·Ongoing·Ontact Inc·July 17, 2024
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·January 22, 2025
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·January 22, 2025
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·January 22, 2025
FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022