50 results · 35ms · Sources: EU EUDAMED, US FDA

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Sofia RSV FIA on Sofia 2 analyzer

FDA 510(k)
FDA Class 1 ·Microbiology

CEMENTED HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304254138·

FETAL DOPPLER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

VERSAFITCUP CC TRIO EXTENSION

FDA 510(k)
FDA Class 2 ·Orthopedic

VERSAFITCUP CC TERMINAL CUP IMPACTOR

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code MEH·June 4, 2014

NA

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·December 4, 2014

ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 20, 2018

VERSAFITCUP CC HIGHCROSS PE LINER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2013

VERSAFITCUP FLAT PE HC LINER Ø 36 / E

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·April 26, 2017

SPRINT QUATTRO SECURE S

FDA Adverse Event
Malfunction ·MPRI·Product code LWS·October 10, 2014

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 13, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 19, 2017

STEM: AMISTEM H HA COATED STD STEM SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 11, 2019

ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

FDA Enforcement
Class III ·Terminated·ECOLAB INC·July 11, 2018

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 5, 2024

VERSAFITCUP FLAT PE HC LINER Ø 32/E

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2016

STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD SIZE 1

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·February 28, 2020

AMISTEM H CEMENTLESS STEM #4 LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code MEH·February 9, 2015

CUP: VERSAFITCUP ACETABULAR SHELL 58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 3, 2020