24 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810103740·15 MIN DNT BASE LT FIBER HC (5# 4 PER CASE)
Vivid Elegance HTS Light FS
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724D0103740·50ml x 4
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890103740·Zirlux Titanium Abutment 6 mmH compatible with:...
SCHMID MEDIZINTECHNIK GMBH
FDA registration
SCHMID MEDIZINTECHNIK GMBH·30 products·🇩🇪 Germany
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL 455GE PHASED ARRAY WRIST COIL
FDA 510(k)
FDA Class 2
·Radiology
8010374-2005-00002
FDA Adverse Event
Other
·Product code FHQ·January 18, 2006
UNK_THERMOCOOL SF NON NAV
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·October 8, 2021
UNK_THERMOCOOL SF NAV
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·October 8, 2021
UNK_SMART TOUCH UNIDIRECTIONAL SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·October 8, 2021
TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code OAE·March 28, 2023
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 19, 2013
GROSHONG CATHETER WITH POWERPORT
FDA Adverse Event
BARD ACESSS SYSTEMS·Product code LJT·February 17, 2011
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024