17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Femoral Trochanteric Nail System Neonail
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Selenite-F Broth
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902210215·BD BBL™ Selenite-F Broth, 8 mL, Carton of 100 s...
FareTec PST
FDA UDI
FARETEC, INC.·B54122210210·FareTec PST, Civilian, orange, no case
Lumbar Interbody Tamp
FDA UDI
XENCO MEDICAL LLC·B064XM12210211·
Tizian Blank 5.0 translucent
FDA UDI
Pritidenta GmbH·04251366905980·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
IQ FLEX M
FDA Adverse Event
Malfunction
·FIRST SOURCE INC.·Product code IZL·May 29, 2024
INOMAX DS (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
FDA 510(k)
FDA Class 2
·Radiology
UNIFY CRT-D
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 3, 2014
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·August 23, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 11, 2013
LOCKING TITANIUM ADAPTER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 12, 2024
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 17, 2021
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024
ARROW Endurance Extended Dwell Peripheral Catheter System
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023