23 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dynamic Axial Fixator
FDA UDI
ORTHOFIX SRL·18032568031966·DRILL BIT DIAMETER 4.8 MM LENGTH 280 MM
Ormco
FDA UDI
ORMCO CORPORATION·00889989027198·SS BROAD ARCH UP SML 0160X0220 PK/10
Cutimed® Cuticell®
FDA UDI
BSN medical GmbH·04042809809572·CUTIMED CUTICELL STERILE 7.5CMX7.5CM 50
Dynamic Axial Fixator
FDA UDI
ORTHOFIX SRL·18033509856099·DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK ...
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869696043·MOSS Screw shank inserter ISR20, 1/4" coupling
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604932·MOSS 100 Pedicle Screw Inserter
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Dental
DRILL BIT DIAMETER 4.8 MM LENGTH 280 MM
FDA Adverse Event
Malfunction
·ORTHOFIX SRL·Product code JDW·March 15, 2023
PERKINELMER NEW CORONAVIRUS NUCLEIC ACID DETECTION KIT
FDA Adverse Event
Malfunction
·PERKINELMER, INC.·Product code QJR·October 4, 2021
MICROFRANCE® INSTRUMENT
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·January 23, 2015
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 8, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·May 18, 2011
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP; g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS; h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090; i) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090JP;
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 5, 2012
TERUMO SURGUARD2 SAFETY NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code MEG·June 17, 2011