BEUDAMED
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    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HRS·September 3, 2021

    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 13, 2021

    T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·June 9, 2021

    T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HXX·April 15, 2021

    EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

    FDA Recall
    Terminated ·Oak Tree International Holdings, LLC, Inc.·Product code NBW·May 26, 2009

    FemSoft Insert, Female Urethral Insert, Size 1 Long, 4.5 cm Length, Sterile (R), Rx Only, REF 72201 or 72201DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code OCK·April 27, 2010

    3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code LWK·January 14, 2019

    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code OBK·September 10, 2013

    FemSoft Insert, Female Urethral Insert, Size 3 Long, 4.5 cm Length, Sterile (R), Rx Only, REF 72203 or 72203DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code OCK·April 27, 2010

    Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code LWK·July 8, 2015

    FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or 71201DT, Sterile (R), Rx Only. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code OCK·April 27, 2010

    FemSoft Insert, Female Urethral Insert, Size 2 Long, 4.5 cm Length, Sterile (R), Rx Only, REF 72202 or 72202DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code OCK·April 27, 2010

    3M Surgical Clipper Professional 9681

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code LWK·February 2, 2018

    FemSoft Insert, Female Urethral Insert, Size 2 Standard, 3.5 cm Length, Sterile (R), Rx Only, REF 71202 or 71202DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code OCK·April 27, 2010

    FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. The Multi-pack products contains 28 devices of the following: -8 of size 1 Standard; -4 of size 2 Standard; -4 of size 3 Standard; -4 of size 1 Long; -4 of size 2 Long; and -4 of size 3 Long.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code OCK·April 27, 2010

    FemSoft Insert, Female Urethral Insert, Size 3 Standard, 3.5 cm Length, Sterile (R), Rx Only, REF 71203 or 71203DT. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code OCK·April 27, 2010

    FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. The FSSTDSUP product is a Clinician Supply Pack that is provided directly to clinics. The Clinician Supply Pack is a package containing 2 multi-pack boxes of product. The corresponding retail box label for this product (FSSTDSUP) is the REF 70200. The Multi-pack products contains 28 devices of the following: -8 of size 1 Standard; -4 of size 2 Standard; -4 of size 3 Standard; -4 of size 1 Long; -4 of size 2 Long; and -4 of size 3 Long.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code OCK·April 27, 2010

    V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.

    FDA Recall
    Terminated ·Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.·Product code GEH·December 5, 2008

    V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.

    FDA Recall
    Terminated ·Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.·Product code GEH·December 5, 2008

    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

    FDA Enforcement
    Class II ·Terminated·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·March 7, 2018