BEUDAMED
    10,000 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Usage: Tracheal tube/airway management

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·June 26, 2019

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·May 8, 2019

    EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case

    FDA Enforcement
    Class II ·Terminated·Medical Depot Inc.·July 6, 2016

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019

    RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·October 15, 2014

    RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·October 15, 2014

    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·October 15, 2014

    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Enforcement
    Class II ·Terminated·SANTA JOY ORNAMENT & GIFTWARE CO·June 13, 2018

    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OMP·August 13, 2014

    RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OMP·July 18, 2014

    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OMP·July 18, 2014

    RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OMP·July 18, 2014

    Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Usage: Tracheal tube/airway management

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTR·May 24, 2019

    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·October 1, 2014

    EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

    FDA Enforcement
    Class I ·Terminated·Nephron Pharmaceuticals Corp.·June 5, 2013

    EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case

    FDA Recall
    Terminated ·Medical Depot Inc.·Product code INP·February 17, 2016

    Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·May 17, 2017

    E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·September 4, 2013

    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

    FDA Enforcement
    Class III ·Terminated·Richard-Allan Scientific Company·August 22, 2018

    EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013