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

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Diagnostic Station DS20

FDA 510(k)
FDA Class 2 ·Cardiovascular

Temptation NOW® A3 8g Bulk

FDA UDI
DEN-MAT HOLDINGS, LLC·00359883006303·Crown and Bridge Temporary Resin

Paxeon Femoral Head

FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200283·Paxeon Head 40mm, CoCr Size L

Femoral Head

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215053550·

Signature Femoral Head

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001780·

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161111520430·Femoral Head, 40mm +4mm (L)

CUSA EXCEL 23KHZ STANDARDTIP

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES (IRELAND) LTD.·Product code LFL·November 24, 2015

3.8MM CS FACET COMPRESSION DEVICE

FDA 510(k)
FDA Unclassified ·Unknown

ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SIGNATURE Head - CoCr

FDA UDI
AMPLITUDE SAS·03701089520706·

ATTAIN ABILITY PLUS

FDA Adverse Event
Malfunction ·MPRI·Product code OJX·June 7, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

PERMASORB 5MM LAPAROSCOPIC 38 CM

FDA Adverse Event
Malfunction ·DAVOL INC.·Product code MAI·August 12, 2008

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 12, 2017

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 27, 2016

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 10, 2017

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 10, 2017

ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 20, 2013

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013