BRAINSCAN WORKSTATION

FDA 510(k)

FDA Class 2 ·Neurology

AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION

FDA 510(k)

FDA Class 2 ·Radiology

BRM3 BRAIN MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

BRM2 BRAIN MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BRAINSCAN BRACHYTHERAPY MODULE

FDA 510(k)

FDA Class 2 ·Radiology

CATHETER VALVES KV 100 & KV 100EH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

FDA 510(k)

FDA Class 2 ·Immunology

Nanox.ARC

FDA 510(k)

FDA Class 2 ·Radiology

Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS

FDA 510(k)

FDA Class 2 ·General Hospital

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA FLEX REAGENT CARTRIDGES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RSV (RADIOLOGY SYSTEM VISIODENT

FDA 510(k)

FDA Class 2 ·Dental

Electrical Neuromuscular Stimulator, Cure Trio

FDA 510(k)

FDA Class 2 ·Neurology

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

FDA 510(k)

FDA Class 2 ·Neurology