17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
FDA 510(k)
FDA Class 2
·Cardiovascular
Implant Prosthetics
FDA UDI
Preat Corporation·00842092117361·NobelBiocare™ Tri-Lobe-compatible RP Esthetic A...
Cervical Plate
FDA UDI
Eisertech, LLC·B5231000570·Cervical Plate Screw Driver
Intellijoint KNEE®
FDA UDI
Intellijoint Surgical Inc·00628184005705·Magnetic Paddle
PenEvac1
FDA UDI
I.C. MEDICAL, INC.·00817688022503·
FLOCATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 4, 2022
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 12, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 1, 2011
KIMBERLY-CLARK TRACH CARE PRODUCTS
FDA Adverse Event
Malfunction
·AVENT S.A. DE C.V.·Product code BTR·February 15, 2008
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:
FDA Enforcement
Class II
·Terminated·Radiometer Medical ApS·April 15, 2020
BrightView X, Gamma Camera, Product Code 882478
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:
FDA Recall
Terminated
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CHL·March 10, 2020
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022