168 results · 28ms · Sources: EU EUDAMED, US FDA

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

FDA 510(k)
FDA Class 2 ·General Hospital

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

FDA 510(k)
FDA Class 2 ·General Hospital

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

FDA 510(k)
FDA Class 2 ·General Hospital

DISPOSABLE SURGICAL GOWNS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EUROPHILIC SLIPPERY COATED FOLEY CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

UNIBLATE ELECTROSURGICAL DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

SUBDERMAL WIRE ELECTRODE, MODEL SWE

FDA 510(k)
FDA Class 2 ·Neurology

PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)

FDA 510(k)
FDA Class 2 ·Neurology

NIKKICART

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Aimanfun Lumea Comfort

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Laser hair growth helmet

FDA 510(k)
FDA Class 2 ·Physical Medicine

Aimanfun Lumea Comfort, A-2789/A-3588

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Laser Hair Growth Comb

FDA 510(k)
FDA Class 2 ·Physical Medicine

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·COMPLETE BRAND LUBRICATING AND REWETTING DROPS

Quantib Brain

FDA 510(k)
FDA Class 2 ·Radiology

Quantib ND

FDA 510(k)
FDA Class 2 ·Radiology

Quantib AI Node

FDA 510(k)
FDA Class 2 ·Radiology