21 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.
FDA Enforcement
Class II
·Terminated·Intel-GE Care Innovations LLC·July 25, 2018
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code OUG·December 6, 2017
Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT220 2.3mm (D) x 20.0 mm (L) STERILE.
FDA Recall
Terminated
·Implant Innovations, Inc.·Product code DZI·December 2, 2003
Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DDK315 LOT Disposable Drill Kit with DT315 STERILE
FDA Recall
Terminated
·Implant Innovations, Inc.·Product code DZI·December 2, 2003
Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE
FDA Recall
Terminated
·Implant Innovations, Inc.·Product code DZI·December 2, 2003
Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DC500 LOT 5.0mm Implant Disposable Countersink Pilot Drill STERILE
FDA Recall
Terminated
·Implant Innovations, Inc.·Product code DZI·December 2, 2003
Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT423 LOT 4.25 mm (D) X 13.0 mm (L) Disposable Twist Drill STERILE
FDA Recall
Terminated
·Implant Innovations, Inc.·Product code DZI·December 2, 2003
Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable.. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
FDA Recall
Terminated
·Oculus Innovative Sciences Inc·Product code FRO·November 9, 2011
Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. 99.999% Reduction In-solution in 30 seconds. MRSA - Staphylococcus aureus VFR - Enterococcus faecalis Acinetobacter baumannii Pseudomonas aeruginosa. Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product. Safe to use around eyes, nose and mouth. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management via debridement of wounds
FDA Recall
Terminated
·Oculus Innovative Sciences Inc·Product code FRO·November 9, 2011
Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics - Does not facilitate resistance - No known drug/treatment interactions or contraindications -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. Oculus Innovative Sciences' Petaluma, CA 94954. Intended to be used by health care professionals in the management in wounds.
FDA Recall
Terminated
·Oculus Innovative Sciences Inc·Product code FRO·November 9, 2011
Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Cardinal Health Medical Products and services, McGaw Park, IL 60085 U.S.A.; There is no label on the Esmark bandage in the Presource pack/module, Some are placed in Tyvek pouches and some are just loose in the pack, but neither have any labeling on them. The Esmark bandage is used to support and compress a part of the patient's body. Presource Packs/Modules are manufactured, according to customer requirements, for use during surgical procedures.
FDA Recall
Terminated
·Cardinal Health·Product code LRO·January 28, 2011
Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment. General and Plastic Surgery: Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment.
FDA Recall
Terminated
·Oculus Innovative Sciences, Inc.·Product code FRO·November 21, 2016
W Vital Health Pulsating Clean Rechargeable Toothbrush; Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015-4616, Made in China; The toothbrush was sold with a single head and with three heads: a) Rechargeable Power Toothbrush - Model Number 565222, UPC 0 49022 35396 1; b) Rechargeable Power Toothbrush with 3 Replacement Heads: Model Number WIC 472641, UPC 0 49022 49612 5; Intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
FDA Recall
Terminated
·Brushpoint Innovations, Inc.·Product code JEQ·January 14, 2011
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LXH·April 1, 2019
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
FDA Recall
Terminated
·Graphic Controls Acquisition Corporation·Product code DRX·March 15, 2022