23 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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