18 results · 22ms · Sources: EU EUDAMED, US FDA

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INTERBODY CAGE

FDA 510(k)
FDA Class 2 ·Orthopedic

QCT Pro Asynchronous Calibration Module, CliniQCT

FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...

CoRoent

FDA UDI
Nuvasive, Inc.·00887517565723·CoRoent Ant TLIF PEEK, 14x10x34mm 8°

Allis Adair Tissue Forceps

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896109704·Allis Adair Tissue Forceps 9 X 10 Teeth

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197053884·SAROT Hemostatic Forceps 240mm,...

BD ECLIPSE¿ NEEDLE FOR LUER LOCK SYRINGES

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 2, 2017

K140347

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

K140347

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

UNIVERSAL CLAMP SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

K-WIRE

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·December 9, 2016

ENDURANT

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code MIH·May 31, 2013

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FPO·June 16, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS DE MEXICO·Product code NIQ·August 28, 2008

HISTOACRYL FLEXIBLE PACK 5

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

FDA Adverse Event
Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH4; 6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5; 7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6; 8) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHA; 9) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHB; 10) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHC; 11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD; 12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE; 13) ENT PACK , Catalog Number: SEN55ENSH2; 14) ENT PACK , Catalog Number: SEN55ENSHA; 15) ENT PACK , Catalog Number: SEN55ENSHB; 16) EYE PACK , Catalog Number: SEY51EYKIK; 17) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH1; 18) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH2; 19) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHB; 20) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHC;;

FDA Enforcement
Class II ·Ongoing·Cardinal Health 200, LLC·January 22, 2025

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022