26 results
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11ms
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Sources: EU EUDAMED, US FDA
a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #68751510105
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·December 18, 2013
DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
FDA Enforcement
Class III
·Terminated·Steris Corporation·September 12, 2012
3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313. b. DYNAREX DynaCare WIPE, WET FLUSHABLE ADULT 9X13" (24/PK 24PK/CS) Catalog # 1322. c. DYNAREX dynacare WIPE, WET FLUSHABLE JR 5X8" (42/BX 12BX/CS) Catalog # 1324
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Model Number: 00303E. b. DERMARITE INDUSTRIES DermaCol Ag Silver Collagen Dressing DermaCol/Ag 2 X 2 Inch Square Sterile Model Number: 00502E
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag 4 X 5 Inch Rectangle Sterile Model Number: DUP88545
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.75 (10/BX 10BX/CS Catalog #177400. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHI-ABSRB AG 2X2 (10/BX 10BX/CS Catalog # 177200
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022