34 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

USTAR II System

FDA 510(k)
FDA Class 2 ·Orthopedic

Phasix

FDA UDI
Davol Inc.·00801741077661·Phasix Mesh, 3" (7.6 cm), Circle

LEONE SPA

FDA UDI
LEONE SPA·08033707069393·LOOP FORMING PLIERS TWEED STYLE

MClass

FDA UDI
Conmed Corporation·10845854020982·MCLASS OSCILLATING SAW BLADE 19 X 1.00 (0.039")...

SOFTSEAL-STF

FDA 510(k)
FDA Unclassified ·Unknown

DIO STEADY EXTERNAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110

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

Widex

FDA UDI
Widex A/S·05706069423860·Widex T-DEX (complete) (DEX silver )

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

SYNCHROMED EL

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code LKK·June 8, 2006

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 1, 2024

FMC ARTERIAL BLOODLINE

FDA Adverse Event
Injury ·FMC USA·Product code FII·March 9, 2000

FLEXIFLO GASTROSTOMY TUBE

FDA Adverse Event
Injury ·ROSS PRODUCTS DIV/ABBOTT LABORATORIES·Product code KNT·May 1, 2001

POLYFLUX

FDA Adverse Event
Injury ·VANTIVE US HEALTHCARE LLC·Product code FJI·May 22, 2025

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

TRILOGY O2

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·June 18, 2013