15 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rainbow Trans
FDA 510(k)
FDA Class 2
·Dental
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM
1.5MM SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036065652·
MaxFuse,VBR, 12 (D) x 14 (W) x 17 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055974·12 (D) x 14 (W) x 17 (H)
COMPACT WHEELCHAIR PLATFORM
FDA 510(k)
FDA Class 2
·Physical Medicine
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
PENUMBRA SYSTEM MAX ASPIRATION TUBING
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 24, 2015
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 6, 2011
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 7, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014