23 results · 28ms · Sources: EU EUDAMED, 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