30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
FDA 510(k)
FDA Class 2
·Immunology
BONE SCREW, CORTICAL
FDA UDI
Biomet Orthopedics, LLC·00887868004759·
LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036284848·
LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036124250·
ProLift
FDA UDI
Life Spine, Inc.·00190837117597·
ZB ProLift Narrow
FDA UDI
Life Spine, Inc.·00190837079338·
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER - FREE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NY-STA BLACK 2/0 18" (45CM) DS24 VPL
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAR·May 5, 2026
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·May 10, 2023
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·January 5, 2024
KIT IMPLANTABLE SLIM TIP LEAD, 90CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·May 10, 2023
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 7, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 28, 2011
VERSACARE SS
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023
SUPRAMID BLACK 3/0 (2) 45CM DS19
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAR·June 13, 2022
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024
DAFILON 3/0 (2) 100M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAR·December 27, 2023