18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPY-PHI System with SPY-PHI Fluorescence Assessment Software
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777617·LUMBAMED BASIC DORSAL STAY WM SILVER IV
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
RELIANCE ENDOSCOPE PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
G-1 VERSION 3, MODEL 10048
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Y-90 THERASPHERE
FDA Adverse Event
Injury
·BIOCOMPATIBLES UK LIMITED·Product code NAW·December 16, 2022
EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·October 19, 2006
UNKNOWN DEPUY PFC CURVED 3X8 TIBIAL INSERT
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 27, 2014
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 28, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·July 15, 2025
SPECTRA OPTIA
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code GKT·December 22, 2022
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 25, 2022
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017