VOLUME COMPUTATION SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

3.7MM/5.0MM DYNAMIC LOCKING SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

DEN TEK COMFORT FIT NIGHTGUARD

FDA 510(k)

FDA Unclassified ·Unknown

TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WATCH-PAT200U (WP200U)

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

THE GRAFTOLOGER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REAMER BIT

FDA 510(k)

FDA Class 1 ·Orthopedic

CRADLE FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

RT300-LSA

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Restorative Therapies, Inc.·1 device

CLAVIA LSA

Basic UDI-DI

EU MDR · Eu Md Class 1 ·BMB MEDICAL·2 devices

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30

FDA 510(k)

FDA Class 2 ·Cardiovascular

BSN Medical

FDA registration

DONGGUAN JOY GROW METAL PRODUCTS LTD·1 product·🇨🇳 China

Resorbable Calcaneo Stop Screw

Basic UDI-DI

EU MDR · Eu Md Class 3 ·LSM-MED S.r.l.·3 devices

LEBO

FDA registration

BIOMATERIALS KOREA INC.·1 product·🇰🇷 South Korea