14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DENTAL CERAMIC
FDA 510(k)
FDA Class 2
·Dental
PROVISA
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975025869·Provisa™ Temporary Cement Mixing Tips Pack of 20
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·July 20, 2022
NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·July 9, 2024
2520274-2013-02152
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·April 26, 2013
LIGHTSPEED VCT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS LLC·Product code JAK·April 22, 2011
PUMP MMT-722CAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 21, 2008
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016
NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 11, 2024
NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 28, 2024
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
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024