23 results · 29ms · 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.

CST61 HIGH SPEED TURBINE HANDPIECE

FDA 510(k)
FDA Class 1 ·Dental

Audit MicroControls Control FD Urine Chemistry

FDA UDI
AALTO SCIENTIFIC·B085K066110·

LEONE SPA

FDA UDI
LEONE SPA·08033707100836·ANATOMICAL EXPANDER ORTHOGONAL ARMS 10mm .

Symmetry Iris

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482040560·Symmetry® Forceps, Iris, Straight, Extremely De...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07310K0131100·Rod Inserter, Fixed, 90 Degree, MIS

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0131100·Rocker, One Piece

MEDCOMP BIO-CATH CATHETER LINE

FDA 510(k)
FDA Class 2 ·General Hospital

ANISEIKONIA INSPECTOR

FDA 510(k)
FDA Class 1 ·Ophthalmic

HNM Medical

FDA UDI
HNM STAINLESS, LLC.·00842962108055·IRIS FORCEPS, 4", 1X2 TEETH, STR

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·May 10, 2018

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

I-STAT CARTRIDGE

FDA Adverse Event
Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 25, 2013

HUT EXT DR FINAL ASSY-STANDARD

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·March 22, 2011

MEDCOMP PICC

FDA Adverse Event
Malfunction ·Product code LJS·June 19, 2008

VENTURE ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·February 10, 2025

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

FDA Recall
Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011