14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100516·THORLAKSON EYE SPECULUM
ProLift
FDA UDI
Life Spine, Inc.·00190837106386·Static Expandable Cage Trial, 10mm x 28mm x 13m...
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XELERIS 2 PROCESSING AND REVIEW WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
PENUMBRA SYSTEM MAX ASPIRATION TUBING
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 24, 2015
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
G7 HI-WALL E1 LINER 36MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·October 30, 2024
ZB 12/14 COCR HD 36MM X +0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 30, 2024
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 7, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023