18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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