96 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO ALPHA DX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
FDA 510(k)
FDA Class 2
·Cardiovascular
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM
FDA Enforcement
Class II
·Terminated·Stryker Corporation·March 25, 2020
BALL HEADS: COCR BALL HEAD 12/14 28 SIZE XL +7
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 24, 2020
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·February 5, 2021
VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 26, 2016
MECTACER BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (USA)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 20, 2023
STEM: AMISTEM H HA COATED LAT STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 21, 2019
QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·May 19, 2016
BD¿ SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 23, 2018
VERSAFITCUP DM HIGHCROSS ACETABULAR LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·September 6, 2013
COROX OTW-L 75-BP
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NKE·April 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·July 24, 2008
CUP: VERSAFITCUP ACETABULAR SHELL Ø 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·November 18, 2019
QUADRA-S 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·August 25, 2021
VERSAFITCUP ACETABULAR SHELL Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·June 9, 2016
VERSAFITCUP ACETABULAR SHELL 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·February 16, 2021
STEM: AMISTEM H COATED STD SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 18, 2020