13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HIVOX Spopad EMS SP-911, SP-921
FDA 510(k)
FDA Class 2
·Physical Medicine
Edge™ Diamond FP016-4C(3.5) Football Pointed
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003360·Diamond dental bur, reusable
BD INSYTE AUTOGUARD IV CATHETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code FOZ·February 9, 2024
ATLANTIS HYPERBARIC CHAMBER VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
PRIMADO2 TOTAL SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16"
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 22, 2023
BD INSYTE AUTOGUARD PNK 20GA X 1.16IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 26, 2024
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 11, 2014
UNKNOWN DEPUY ACETABULAR CUP
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 27, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·May 14, 2025
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code HBC·March 26, 2018
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014