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HEATER BASE, MODEL PMH7000

FDA 510(k)
FDA Class 2 ·Anesthesiology

TruForm

FDA UDI
Rmo, Inc.·00885797099693·MAN MLR BDS ASST 100 SE ASIA

Symmetry Malis®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482035979·Symmetry® Bipolar Forceps; Hardy Bayonet; Strai...

WUJIN #3 FEMORAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

NOVABONE-BIOGLASS BONE GRAFT PARTICULATE

FDA 510(k)
FDA Class 2 ·Dental

DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 6, 2011

LCS COMPLETE FEM CEM R STD+

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·July 18, 2008

Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014