Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coro

DT-L-725;DT-L-726;DT-L-727;DT-L-728;DT-L-729;DT-L-730;DT-L-731;DT-W-622;DT-Z-612;DT-Z-613;DT-Z-614;DT-Z-615;

FDA registration

BEIJING BOHAIKANGYUAN MEDICAL DEVICES CO.,LTD.·1 product·🇨🇳 China

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP; Corox OTW-L BP; Corox ProMRI OTW BP; Sentus ProMRI OTW QP S; Sentus ProMRI OTW QP S-xx/49; Corox OTW-S BP;

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, 85, 95, L-75, 85, 95, Sentus ProMRI OTW QP S-75/49, 85/49, 95/49, L-75/49, 85/49, 9/49 and Se

DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GENEX BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOLOK SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PROCLEAR DAILY WEAR CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

BILOK ST SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories

FDA 510(k)

FDA Class 2 ·General Hospital

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

FORTOSS-CEMA

FDA 510(k)

FDA Class 2 ·Dental

STIMULAN -CALCIUM SULFATE BONE VOID FILTER

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOLOK SCREW, BIOSTEON SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOSTEON CROSS PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

LITTLE GRAFTER SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

SHARK Lumbar Spacer System

FDA UDI

Choice Spine, LP·00840996160520·PLI,SPACER,SHARK,Ti,9,25X16,4 DEG

Octane Straight IR

FDA UDI

Choice Spine, LP·00840996163743·OCTANE STRAIGHT IR, Ti, 36X10X14, 6 DEG

SHARK Lumbar Spacer System

FDA UDI

Choice Spine, LP·00840996160599·PLI,SPACER,SHARK,Ti,9,28X11,4 DEG