73 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION PACK P966455A BREAST BIOPSY PACK-LF
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020
CMS-5284 Custom Myelogram Tray 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
CMS-2586 Custom Amnio Tray 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
CMS-4975 HSG 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
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
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
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep 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
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle 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
CMS-8495-R5 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
CMS-4316 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
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
Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.
FDA Enforcement
Class II
·Terminated·Bard Medical Division·September 5, 2018
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
VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUCTION CONNECT. W' X 12' LIF (1) GOWN SURG REINF XL T/WRAP (20) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) PENCIL CAUTERY HAND SWITCHING (1) PVP PAINT 8" STICK SPONGE (1) PVP SCRUB 8" STICK SPONGE (1) SYRINGE 20cc W/0 NDL LUER LOCK LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) PRE PAD WITH CUFF (1) PACKING VAGINAL XRD 4" X 36" 8PLY (2) PAD OBSTETRICAL XL (1) CATHETER 2/W 16Fr. PRESS W/UBAG 2000ML (1) TIME OUT BEACON NON WOVEN LIF 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
LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUCH (5) LAP SPONGES PREWASH XRD L/F (1) NEEDLE HYPODERMIC 18G X 1 %" (1) MAYO STAND COVER REINFORCED LIF (1) UTILITY BOWL 32oz. L/F (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (4) TOWEL ABSORBENT 15" X 20" L/F (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CLOTH HUCK TOWEL BLUE L/F (1) PVP PAINT 8" STICK SPONGE (4) DRAPE UTILITY WITH TAPE LIF (2) UTILITY BOWL 16oz LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) PVP SCRUB 8" STICK SPONGES (1) CLIPS LIGATING TIT M/L (L T 300) (4) TEGADERM 2 3/8 X 2% L/F (4) GOWN SURG. REINFORCED LARGE TOWEL/WRAP 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
CATHETER SECUREMENT SYSTEM
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018
TUBING CHANGE KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018
BLOOD DRAW KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 28, 2018