17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894127261·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605517·MAQUET 1130 ORTHOPEDIC 5" SOFTCARE PLUS
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182741·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867032170·SIZER, ALLOGRAFT OATS 27.5MM
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476514·
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742102955·ADARA ø4.5mm Cortical Screw, Full Thread, SS - ...
DRYSTAR 4500 PRINTER, MODEL 4500
FDA 510(k)
FDA Class 2
·Radiology
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
FDA Adverse Event
Injury
·ZEST ANCHORS, INC.·Product code DZE·April 24, 2013
ACCU-CHEK FLEXLINK PLUS INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 6, 2011
INNOVA 3100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code IZI·July 22, 2008
HOT SHEARS (TM) (MONOPOLAR CURVED SCISSORS)
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 17, 2012
HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018
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