19 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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Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
FDA 510(k)
FDA Class 2
·Hematology
AVANOS*
FDA UDI
Avanos Medical, Inc.·00193493935079·Quincke Needle
HeatWave™ Calipers
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012980·Dental measuring instrument
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270756·
Halyard
FDA UDI
Avanos Medical, Inc.·10680651935073·
AGILE NAIL
FDA UDI
ORTHOFIX SRL·18054242518990·TARGETING HANDLE
OSE
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042123366·1000 Stainless Steel Ligature Ties - .010
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027725·Seletz Gelpi Ret, arms bent at rt ang, 6 3/4"
MOUNTAINEER OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
FDA 510(k)
FDA Class 2
·Dental
COOLSCULPTING SYSTEM
FDA Adverse Event
Injury
·ALLERGAN PLEASANTON·Product code OOK·October 9, 2021
VANGUARD PS TIBIAL BEARING 10X63/67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 6, 2017
ARTERIAL BLOOD LINE
FDA Adverse Event
Injury
·NATIONAL MEDICAL CARE·Product code FJK·July 25, 1995
BIOMET CC CRUCIATE TRAY 67 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 6, 2017
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 21, 2013
TAXUS® EXPRESS²®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 28, 2011
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·January 4, 2017
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 8, 2017