86 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Tasso+
FDA UDI
Tasso Inc.·00850038691004·
STALIF MIDLINE
FDA 510(k)
FDA Class 2
·Orthopedic
Preat
FDA UDI
Preat Corporation·00842092108628·Preci-Sagix Starter Kit Plastic Male . Kit Cont...
Dynamic Axial Fixator
FDA UDI
ORTHOFIX SRL·18032568032079·CANNULATED DRILL BIT L 150 MM D 3.2 MM 1.8 MM ...
FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301
FDA 510(k)
FDA Class 2
·Clinical Chemistry
L1
FDA UDI
KLS-Martin L.P.·00888118141996·BASE, PLATE, 135 SCREWS
AVANTAGE CMNTD SHELL SS 44MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 22, 2025
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151158·Instrument Tray Base #1, PSS (MP)
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151165·Instrument Tray Base #2, PSS (MP)
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151318·Instrument Tray Insert #1 for Base #1, PSS (MP)
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151325·Instrument Tray Insert #1 for Base #2, PSS (MP)
OPAL BOND FLOW
FDA 510(k)
FDA Class 2
·Dental
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
FDA 510(k)
FDA Class 2
·Cardiovascular
PLASMAFLOW
FDA Adverse Event
Malfunction
·MANAMED·Product code JOW·February 21, 2025
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 24, 2011
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012