BEUDAMED
    22 results · 105ms · Sources: EU EUDAMED, US FDA

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    NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code KKX·June 6, 2011

    NON-STERILE DISPOSABLE SURGICAL DRAPES

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·NUREL MEDİKAL SANAYİ VE TİCARET ANONİM ŞİRKETİ·30 devices

    PHASTIPP DISPOSABLE RESECTOR

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code DWQ·March 10, 2023

    INTRALASE FS3

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code HNO·December 26, 2018

    COLOR CUFF

    FDA Adverse Event
    Malfunction ·STRYKER CORPORATION·Product code KCY·March 14, 2023

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL,INC.·Product code NAY·April 12, 2012

    CAUTERY HIGH TEMP LOOP TIP

    FDA Adverse Event
    Injury ·BOVIE MEDICAL CORP.·Product code HQP·November 15, 2017

    AQUABEAM ROBOTIC SYSTEM

    FDA Adverse Event
    Malfunction ·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·January 20, 2023

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·February 9, 2016

    ALCON OPTEMP II CAUTERY

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code HQP·March 31, 2010

    Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Product Code 44968 00; C-Section Drape with Pouch and Fenestration (Non-Sterile), Product Code 44977 NS; C-Section Drape with Pouch and Fenestration (Sterile), Product Code 44978 00 Product Usage: A surgical drape is a device made of natural or synthetic materials intended to be use as a protective patient covering, such as to isolate a site or surgical incision from microbial and other contamination.

    FDA Recall
    Terminated ·Halyard Health, Inc·Product code KKX·November 9, 2016

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FQH·May 13, 2015

    UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code GEI·July 23, 2020

    Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60" X 77" LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F (2) DRAPE SIDE 42" X 76" WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8" ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2" X 4" 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

    Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-sterile; Surgical Room Turnover (SRT) Kits: (3) Ecolab Genesys CleanOp Infection Control System, Model ALHS-02, 12/case, non-sterile; (4) Ecolab Genesys CleanOp Infection Control System, Model ALHS-SS-01, 12/case, non-sterile; (5) Ecolab CleanOp Infection Control System, Model BPGN-02, 10/case, non-sterile; (6) Ecolab Genesys CleanOp Infection Control System, Model HFH-02, 12/case, non-sterile; (7) Ecolab Genesys CleanOp Infection Control System, Model HKHA-02, 15/case, non-sterile; (8) Ecolab CleanOp Infection Control System, Model JFKSC-01, 15/case, non-sterile; (9) Ecolab Genesys CleanOp Infection Control System, Model LH-LD-05, 12/case, non-sterile; (10) Ecolab CleanOp Infection Control System, Model NEGM-CV-01D, 9/case, non-sterile; (11) Ecolab Genesys CleanOp Infection Control System, Model PMMC-02D, 12/case, non-sterile; (12) Ecolab Genesys CleanOp Infection Control System, Model PMMC-SP-01D, 12/case, non-sterile; (13) Ecolab Genesys CleanOp Infection Control System, Model SHMC-06, 15/case, non-sterile; (14) Ecolab CleanOp Infection Control System, Model SR-01D, 12/case, non-sterile; (15) Ecolab CleanOp Infection Control System, Model SVB-OSC-01, 12/case, non-sterile; (16) Ecolab CleanOp Infection Control System, Model UCLA-LD-03, 12/case, non-sterile; (17) Ecolab CleanOp Infection Control System, Model VAIC-03, 12/case, non-sterile; and (18) Ecolab Genesys CleanOp Infection Control System, Model VAIC-CP-02, 15/case, non-sterile.

    FDA Recall
    Open, Classified ·Microtek Medical Inc.·Product code KME·June 23, 2023

    Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60" X 77" LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F (2) DRAPE SIDE 42" X 76" WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8" ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2" X 4" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014

    Flamingo Funnel Large, Model Number SQ20012-03

    FDA Recall
    Open, Classified ·SurgiSmoke Solutions·Product code FYD·March 16, 2026