Forceps, Wire Closure, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Forceps, Wire Closure, Ent, Non-Sterile

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory; Zephyr; Accent; Assurity; Assurity+; Endurity; Identity XL, Identity ADx XL; Verity ADxXL

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR

LeukoStrat CDx FLT3 Mutation Assay

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Invivoscribe, Inc.·2 devices

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NARKOMED MRI , NM-MRI

FDA 510(k)

FDA Class 2 ·Anesthesiology

ISSYS DRUG FLOW MONITOR

FDA 510(k)

FDA Class 2 ·General Hospital

NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY

FDA 510(k)

FDA Class 2 ·Orthopedic

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Rezum System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

ST'RIM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOACTIVE BONE GRAFT PUTTY

FDA 510(k)

FDA Class 2 ·Orthopedic

RADIANCE 330 PROTON THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ONCO TRAC MODEL 1, 2, 4

FDA 510(k)

FDA Class 2 ·Radiology