Zygomatic Implants

FDA 510(k)

FDA Class 2 ·Dental

Neodent Instrument Kit Cases

FDA 510(k)

FDA Class 2 ·General Hospital

NUVO Implant System – NUVO Instrument Kit Cases

FDA 510(k)

FDA Class 2 ·General Hospital

REMOTEYE VIEWER

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·NDS LENS MAINTENANCE SYSTEM

Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

FDA classification

FDA Class 2 ·Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA

FDA 510(k)

FDA Class 2 ·Anesthesiology

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE(TM) CORONARY BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC MERLIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER