30 results · 23ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO RAICHEM CALCIUM REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Safco T&F Bur - 12 Bladed

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310220493·Safco T&F bur - 12 bladed, carbide, #7214 taper...

LINK Instruments - Trial implants and size gauges

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575408993·Acetabulum prosthesis trial, reusable - Vario-C...

INVERNESS MEDICAL EARLY PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FORTAFLEX SURGICAL MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HEARTWARE HVAD

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·March 26, 2013

EYE SURGERY STRETCHER OBS

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·March 10, 2011

BIOFLEX TESIO CATH

FDA Adverse Event
Malfunction ·MEDCOMP·Product code MSD·March 28, 2008

Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24

FDA Enforcement
Class II ·Ongoing·ICU Medical Inc.·September 10, 2025

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER INC.·Product code MMI·December 20, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011

UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·December 22, 2011