Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·(LGW, QRB) - Master Restore Spinal Cord Stimulation Systems

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Q Guidance System; Mako Spine System;

FDA 510(k)

FDA Class 2 ·Neurology

MitraClip G4 Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Merit1383 (TM) - DriPAD Super Absorbent Pad

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

OREX MEDICAL BEDDING

FDA 510(k)

FDA Class 1 ·General Hospital

MEDICAL, DISPOSABLE BEDDING

FDA 510(k)

FDA Class 1 ·General Hospital

BEDDING, DISPOSABLE HOSPITAL

FDA 510(k)

FDA Class 1 ·General Hospital

PAD, BED LINEN PROTECTIVE

FDA 510(k)

FDA Class 1 ·General Hospital

BED SHEET, PILLOW CASE

FDA 510(k)

FDA Class 1 ·General Hospital

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

3M THINSULATE DISPOSABLE HOSPITAL BED

FDA 510(k)

FDA Class 1 ·General Hospital