Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT

Vydence Zye and Vydence One

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Etherea MX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HandPICO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE

FDA 510(k)

FDA Class 2 ·Anesthesiology

PAINTED WEDGE & ROD BREAST BOARD

FDA 510(k)

FDA Class 2 ·Radiology

STERISPINE CC

FDA 510(k)

FDA Class 2 ·Orthopedic

DICOMIT

FDA 510(k)

FDA Class 2 ·Radiology

STERISPINE PS

FDA 510(k)

FDA Class 2 ·Orthopedic

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AccuContour

FDA 510(k)

FDA Class 2 ·Radiology

ACRYSTEEL BLOCKING TRAY

FDA 510(k)

FDA Class 2 ·Radiology

FLOWSCAN

FDA 510(k)

FDA Class 2 ·Anesthesiology

Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ND: YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUDIOSCAN

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MED-TEC HAND GRIP

FDA 510(k)

FDA Class 2 ·Radiology

Distal Access Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular