RANDOX LABORATORIES LIMITED D400-0018 L SOLN

A non-sterile device made of natural latex intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes.

Powder-free textured; The packages of proposed device including middle box package and outer carton package.Middle box package quantity: 100PCSOuter carton package quantity: 2000PCS

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)

RITA Habib 4X Bipolar Resection Device, 10cm

Tinted Liquid

The TECOtherm Wrabbit is designed as disposable device to help prevent postnatal heat and water loss in premature and newborn infants.

EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts andabsorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy,and reconstruction. The device is intended for single use and should be changed daily or according to doctor’s instructions.

STERILE DISPOSABLE TOURNIQUET CUFF,SINGLE PORT, SINGLE BLADDER, SIZE L, 34 IN

A non-sterile device made of Nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes.

A non-sterile device made of natural latex intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes.

Powder-free textured; The packages of proposed device including middle box package and outer carton package.Middle box package quantity: 100PCSOuter carton package quantity: 2000PCS

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)