23 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·July 11, 2014
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
FDA Recall
Terminated
·Covidien LLC·Product code MGQ·March 3, 2017
Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
FDA Recall
Terminated
·DeRoyal Wound Care·Product code MGQ·July 8, 2004
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·July 11, 2014
Amerigel Daily Dressing Packets Wound management
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·September 26, 2014
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·July 11, 2014
Amerigel Wound Dressing 55 gallons/drum
FDA Recall
Terminated
·Kova Laboratories, Inc.·Product code MGQ·March 21, 2014
Amerigel Wound Dressing 1 oz. tube
FDA Recall
Terminated
·Kova Laboratories, Inc.·Product code MGQ·March 21, 2014
Amerigel Saturated Gauze Dressing Wound management
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·September 26, 2014
Amerigel Hydrogel Wound Dressing Wound management
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·September 26, 2014
Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·July 11, 2014
Amerigel Post-op Surgical Kits Wound management
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·September 26, 2014
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
FDA Recall
Terminated
·Amerx Health Care Corp.·Product code MGQ·February 25, 2015
Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.
FDA Recall
Terminated
·PhotoMedex, Inc.·Product code MGQ·March 26, 2015
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 21, 2018
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 2, 2016
NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·September 29, 2017
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·January 18, 2016
ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·April 13, 2015
ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015