BEUDAMED
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    Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·May 22, 2019

    Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.

    FDA Recall
    Terminated ·Integra Limited·Product code KGN·March 31, 2019

    Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

    FDA Recall
    Terminated ·Avid Medical, Inc.·Product code LRO·October 5, 2015

    Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

    FDA Recall
    Terminated ·Avid Medical, Inc.·Product code LRO·October 5, 2015

    Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020 VAGINAL DELIVERY TRAY MNS11040 OB DELIVERY PROCEDURE PACK MNS11040 OB DELIVERY PROCEDURE PACK MNS11180 CUTDOWN TRAY MNS11380 CYSTO PROCEDURE KIT MNS11415 BIRTHING SET MNS11430 MYELOGRAM TRAY MNS11485 DERM ROOM TRAY MNS11490 VASECTOMY TRAY MNS11490 VASECTOMY TRAY MNS11605 STERILE FLUORO SSP TRAY MNS11720 OCULOPLASTICS INSTRUMENT SET MNS11780 MOHS INSTRUMENT PACK MNS11885 OB BASIC DELIVERY INSTRUMENT TRAY MNS11980 DERMATOLOGY TRAY MNS12045 LINE REPAIR KIT MNS12090 TOENAIL REMOVAL PACK MNS12140 HAND TRAY MNS12175 PACEMAKER TRAY MNS1320 E.N.T. TRAY MNS1445 VASECTOMY MNS1485 NOSEBLEED TRAY MNS1500 JOINT ASPIRATION KIT MNS1500 JOINT ASPIRATION KIT MNS1545 LATEX FREE NASAL HEMORRHAGE SET MNS1555 EPISTAXIS TRAY MNS1900 NOSEBLEED TRAY MNS1990 NASAL KIT MNS2105 EPISTAXIS TRAY MNS2170 NASAL PACKING TRAY MNS2225B MYELOGRAM TRAY MNS2225B MYELOGRAM TRAY MNS2845 U/S, BASIC BIOPSY TRAY MNS2975 ENT EPISTAXIS TRAY MNS3345A PEDIATRIC CUTDOWN TRAY MNS3450 IUD TRAY MNS3490 CHEMO KIT MNS3925 OB INSTRUMENT TRAY MNS4090A MINOR CUTDOWN TRAY MNS4110 THORACOTOMY TRAY MNS4120 NOSEBLEED TRAY MNS4215 OR VAGINAL DELIVERY TRAY MNS4360 BREAST BIOPSY KIT MNS4405 BIOPSY DERMATOLOGY KIT MNS4545 NASAL TRAY MNS4855 WOUND EXPLORATION/DPL TRAY MNS5170 NEONATAL PROCEDURE TRAY MNS5225 RENAL BIOPSY TRAY MNS5272 OB DELIVERY INSTRUMENT TRAY MNS5410 VAG DELIVERY INSTRUMENTS MNS5410 VAG DELIVERY INSTRUMENTS MNS5425 VAGINAL DELIVERY TRAY MNS5511 ARTHROGRAM TRAY MNS5575 OB DELIVERY TRAY MNS5750A VAGINAL DELIVERY SET MNS6025 GU MEATOTOMY MNS6025 GU MEATOTOMY MNS6260 BIOPSY TRAY MNS6285 MINOR PLASTIC SET MNS6395 VAGINAL DELIVERY KIT MNS6405 MULTI-PURPOSE RADIOLOGY TRAY MNS6820 RADIOLOGIST SPINAL TRAY MNS6880 BIOPSY TRAY MNS6985 PERCUTANEOUS CATHETER PLACEMENT TRAY MNS7155 TONGUE TIE KIT MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7295 BIOPSY KIT - SHAVE/PUNCH COMBO MNS7325 CATHETER REMOVAL TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7575 MINOR TISSUE TRAY MNS7605 BREAST BIOPSY KIT MNS7815 DERMAL PACK MNS7900 C.T. BIOPSY TRAY MNS8010 EPISTAXIS TRAY MNS8445 SPINAL TRAY MNS8445 SPINAL TRAY MNS8475 ED TRACHEOTOMY TRAY MNS8645 BIOPSY KIT MNS8645 BIOPSY KIT MNS8915 BLOOD CULTURE COLLECTION KIT ; CVAD MNS9005 CENTRAL LINE REMOVAL TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9170 CUTDOWN TRAY MNS9245 PACEMAKER TRAY MNS9335 IUD TRAY MNS9455 VAGINAL DELIVERY TRAY W/INSTRUMENTS MNS9480 VAGINAL DELIVERY TRAY MNS9480 VAGINAL DELIVERY TRAY MNS9625 TRACHEOSTOMY KIT MNS965 AMNIOCENTESIS TRAY MNS9710 IUD TRAY MNS9765 PORT INSERTION TRAY MNS9780 ARTHROGRAM TRAY MNS9820 OB PACK MNS9835 VAG DELIVERY TRAY MNS9835 VAG DELIVERY TRAY MNS9855 PACEMAKER INSTRUMENT TRAY MNS9870 DR. NELSON MOHS PACK MNS9870 DR. NELSON MOHS PACK MNS9935 CATH LAB INSTRUMENT KIT

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·August 24, 2016

    Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·August 24, 2016

    Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

    Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020 VAGINAL DELIVERY TRAY MNS11040 OB DELIVERY PROCEDURE PACK MNS11040 OB DELIVERY PROCEDURE PACK MNS11180 CUTDOWN TRAY MNS11380 CYSTO PROCEDURE KIT MNS11415 BIRTHING SET MNS11430 MYELOGRAM TRAY MNS11485 DERM ROOM TRAY MNS11490 VASECTOMY TRAY MNS11490 VASECTOMY TRAY MNS11605 STERILE FLUORO SSP TRAY MNS11720 OCULOPLASTICS INSTRUMENT SET MNS11780 MOHS INSTRUMENT PACK MNS11885 OB BASIC DELIVERY INSTRUMENT TRAY MNS11980 DERMATOLOGY TRAY MNS12045 LINE REPAIR KIT MNS12090 TOENAIL REMOVAL PACK MNS12140 HAND TRAY MNS12175 PACEMAKER TRAY MNS1320 E.N.T. TRAY MNS1445 VASECTOMY MNS1485 NOSEBLEED TRAY MNS1500 JOINT ASPIRATION KIT MNS1500 JOINT ASPIRATION KIT MNS1545 LATEX FREE NASAL HEMORRHAGE SET MNS1555 EPISTAXIS TRAY MNS1900 NOSEBLEED TRAY MNS1990 NASAL KIT MNS2105 EPISTAXIS TRAY MNS2170 NASAL PACKING TRAY MNS2225B MYELOGRAM TRAY MNS2225B MYELOGRAM TRAY MNS2845 U/S, BASIC BIOPSY TRAY MNS2975 ENT EPISTAXIS TRAY MNS3345A PEDIATRIC CUTDOWN TRAY MNS3450 IUD TRAY MNS3490 CHEMO KIT MNS3925 OB INSTRUMENT TRAY MNS4090A MINOR CUTDOWN TRAY MNS4110 THORACOTOMY TRAY MNS4120 NOSEBLEED TRAY MNS4215 OR VAGINAL DELIVERY TRAY MNS4360 BREAST BIOPSY KIT MNS4405 BIOPSY DERMATOLOGY KIT MNS4545 NASAL TRAY MNS4855 WOUND EXPLORATION/DPL TRAY MNS5170 NEONATAL PROCEDURE TRAY MNS5225 RENAL BIOPSY TRAY MNS5272 OB DELIVERY INSTRUMENT TRAY MNS5410 VAG DELIVERY INSTRUMENTS MNS5410 VAG DELIVERY INSTRUMENTS MNS5425 VAGINAL DELIVERY TRAY MNS5511 ARTHROGRAM TRAY MNS5575 OB DELIVERY TRAY MNS5750A VAGINAL DELIVERY SET MNS6025 GU MEATOTOMY MNS6025 GU MEATOTOMY MNS6260 BIOPSY TRAY MNS6285 MINOR PLASTIC SET MNS6395 VAGINAL DELIVERY KIT MNS6405 MULTI-PURPOSE RADIOLOGY TRAY MNS6820 RADIOLOGIST SPINAL TRAY MNS6880 BIOPSY TRAY MNS6985 PERCUTANEOUS CATHETER PLACEMENT TRAY MNS7155 TONGUE TIE KIT MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7295 BIOPSY KIT - SHAVE/PUNCH COMBO MNS7325 CATHETER REMOVAL TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7575 MINOR TISSUE TRAY MNS7605 BREAST BIOPSY KIT MNS7815 DERMAL PACK MNS7900 C.T. BIOPSY TRAY MNS8010 EPISTAXIS TRAY MNS8445 SPINAL TRAY MNS8445 SPINAL TRAY MNS8475 ED TRACHEOTOMY TRAY MNS8645 BIOPSY KIT MNS8645 BIOPSY KIT MNS8915 BLOOD CULTURE COLLECTION KIT ; CVAD MNS9005 CENTRAL LINE REMOVAL TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9170 CUTDOWN TRAY MNS9245 PACEMAKER TRAY MNS9335 IUD TRAY MNS9455 VAGINAL DELIVERY TRAY W/INSTRUMENTS MNS9480 VAGINAL DELIVERY TRAY MNS9480 VAGINAL DELIVERY TRAY MNS9625 TRACHEOSTOMY KIT MNS965 AMNIOCENTESIS TRAY MNS9710 IUD TRAY MNS9765 PORT INSERTION TRAY MNS9780 ARTHROGRAM TRAY MNS9820 OB PACK MNS9835 VAG DELIVERY TRAY MNS9835 VAG DELIVERY TRAY MNS9855 PACEMAKER INSTRUMENT TRAY MNS9870 DR. NELSON MOHS PACK MNS9870 DR. NELSON MOHS PACK MNS9935 CATH LAB INSTRUMENT KIT

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code LRP·December 11, 2019

    Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

    Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.

    FDA Enforcement
    Class II ·Terminated·Anika Therapeutics, Inc.·July 18, 2018

    Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.

    FDA Recall
    Terminated ·Anika Therapeutics, Inc.·Product code FRO·May 10, 2018

    Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit

    FDA Recall
    Terminated ·Covidien LLC·Product code FSY·April 16, 2015

    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code JOH·December 16, 2005

    Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36118, C-PTBSY-2600-PERC6.

    FDA Recall
    Terminated ·Cook, Inc.·Product code JOH·April 21, 2010

    Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien Ltd)·Product code JOH·April 13, 2010