MODIFIED THERMAL WELL TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

GEM-TONE BODY TRAINING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

GEMORE TENS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)

FDA 510(k)

FDA Class 2 ·Neurology

GEM-STIM TENS, MODELS GM3XY AND GM3AXY

FDA 510(k)

FDA Class 2 ·Neurology

MON-A-THERM'S SKIN TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

Urinary Drainage Bag Holder

FDA UDI

DYNAREX CORPORATION·00616784026138·

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D

Qlicksmart BladeFlask UNIVERSAL

FDA 510(k)

FDA Class 2 ·General Hospital

VENUS CERVICAL SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Urocare® Pliable White-Rubber Drainage Tubing, Medium 0.28" I.D. x 10 ft.

FDA UDI

UROCARE PRODUCTS, INC.·00792293608284·TUBING, URINE COLLECTION, PLIABLE, WHITE-RUBBER...

Urocare® Pliable White-Rubber Drainage Tubing, Large 0.31" I.D. x 10 ft.

FDA UDI

UROCARE PRODUCTS, INC.·00792293608314·TUBING, URINE COLLECTION, PLIABLE, WHITE-RUBBER...

Urocare® Tubing Connector, Large 0.38" OD x 2.25"

FDA UDI

UROCARE PRODUCTS, INC.·00792293060105·TUBING, URINE COLLECTION, OSTOMY, WHITE-RUBBER,...

Urocare® Pliable White-Rubber Drainage Tubing, Small 0.25" I.D. x 10 ft.

FDA UDI

UROCARE PRODUCTS, INC.·00792293608253·TUBING, URINE COLLECTION, PLIABLE, WHITE-RUBBER...

Urocare® Catheter Connector, Small 0.31" OD x 3"

FDA UDI

UROCARE PRODUCTS, INC.·00792293060136·TUBING, URINE COLLECTION, OSTOMY, WHITE-RUBBER,...

Urocare® Tubing Connector, Small 0.31" OD x 2.25"

FDA UDI

UROCARE PRODUCTS, INC.·00792293060099·TUBING, URINE COLLECTION, OSTOMY, WHITE-RUBBER,...

Urocare® Catheter Connector, Large 0.38" OD x 3"

FDA UDI

UROCARE PRODUCTS, INC.·00792293060143·TUBING, URINE COLLECTION, OSTOMY, WHITE-RUBBER,...