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

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MDRIVE

FDA 510(k)
FDA Class 2 ·Anesthesiology

MAXCUT CARBIDE BUR (10/pk) FGSU # 702

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811117421·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...

ONESTEP ADULT MULTI-FUNCTION ELECTRODE

FDA 510(k)
FDA Class 3 ·Cardiovascular

THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 29, 2015

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·June 11, 2014

SIMPLEX P-JAPANESE TWIN PACK

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LOD·May 14, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011

MIRAGE .008 HYDROPHILIC GUIDEWIRE

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code DQX·August 13, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 25, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 25, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 22, 2017

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·May 6, 2022

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·May 6, 2022

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 22, 2017

CD HORIZON - CHROMALOY PLUS ROD

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 22, 2020

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 4, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025