HAND-TROL S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE ELECTROSURGERY BALL ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAHE INSTRUMENTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DCG DATA TERMINAL

FDA 510(k)

DCG PREAMPLIFIER MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DCG-VII ELECTROCARDIOSCANNER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)

FDA 510(k)

FDA Class 2 ·Orthopedic

IDECAP DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UV VISIBLE SPECTROPHOTOMETERS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ASTar BC G- Kit and ASTar Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

FDA 510(k)

FDA Class 2 ·Radiology

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ScandiDos Delta4 Phantom+

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology