16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Eclipse Treatment Planning System
FDA 510(k)
FDA Class 2
·Radiology
Border-Lock® Upper Tray #45
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015837·Dental impression tray, single-use
Free-Lock®
FDA UDI
Zimmer, Inc.·00889024035508·
Free-Lock®
FDA UDI
Zimmer, Inc.·00889024035492·
MODIFICATION TO 4CIS VANE SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 16, 2003
TRUETRACK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·January 26, 2018
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 2, 2008
COULTER® LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 21, 2013
TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIA
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HRS·July 8, 2011
Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·April 24, 2019
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.
FDA Recall
Terminated
·Zimmer, Inc.·Product code KTT·June 19, 2013
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 4, 2013
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026