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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013
CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Enforcement
Class II
·Terminated·LivaNova USA Inc·February 5, 2020
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
FDA Enforcement
Class II
·Terminated·MEDLINE IND·January 18, 2017
Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth
FDA Enforcement
Class II
·Terminated·GlaxoSmithKline, LLC.·November 20, 2013
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
FDA Enforcement
Class II
·Terminated·Westone Laboratories, Inc.·August 1, 2012
Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
FDA Enforcement
Class II
·Terminated·Conseal International, Inc.·May 9, 2018
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·March 16, 2016
HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.
FDA Enforcement
Class II
·Terminated·Bio-Signal Group Corp.·December 25, 2019
HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.
FDA Enforcement
Class II
·Terminated·Bio-Signal Group Corp.·December 25, 2019
CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·June 23, 2021
GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( 1) SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF (1) SURGICAL BLADE# 10 STAINLESS STEEL ( 1) SURGICAL DURAPREP SOLUTION 26mL LIF ( 1) LAPAROTOMY T DRAPE STD SMS (2) DRAPE SHEET 41" X 58" SMS LIF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1 0) GAUZE 4"X 4" X 4 PLY ( 1) CAUTERY TIP POLISHER LIF (5) LAP SPONGES PRE-WASH XRD LIF ( 1) CAUTERY PENCIL ROCKER SWITCH LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF ( 1) TUBE SUCTION CONNECT. 3/16" X 12' LIF ( 1) SURGICAL BLADE# 15 CARBON STEEL ( 1) CONTAINER SPECIMEN 4 oz. WITH LID & LABEL Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014