16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 17, 2026
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
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741054·Boys-Allis Tissue Forceps 6" (15.2cm), 5x6 teet...
CYFRA 21-1 EIA MODEL 211-10
FDA 510(k)
FDA Class 2
·Immunology
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
FDA 510(k)
FDA Class 2
·Cardiovascular
REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
FDA Adverse Event
Injury
·SHASER INC·Product code ONF·May 21, 2021
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 3, 2014
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
UNKNOWN·Product code INM·May 31, 2013
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 31, 2011
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
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013