19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYDRAVIEW GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
FDA 510(k)
FDA Class 2
·Hematology
PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
FDA 510(k)
FDA Class 2
·Dental
AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025
AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024
MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 17, 2026
AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026
AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023
BD MAXZERO¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015