37 results
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18ms
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Sources: EU EUDAMED, US FDA
MYERSON'S SPECIAL CROWN & BRIDGE RESIN
FDA 510(k)
FDA Class 2
·Dental
HEART STABILIZER FINGER ATTACHMENT
FDA UDI
SONTEC INSTRUMENTS, INC.·B09928008280·HEARTLINE HEART STABILIZER FINGER ATTACHMENT 2S...
HEART STABILIZER FINGER ATTACHMENT
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896070301·HEARTLINE HEART STABILIZER FINGER ATTACHMENT 2S...
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
MOUNTAINEER OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COMP RVS CNTRL SCR 6.5X20MM ST
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·May 8, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·October 17, 2012
UNKNOWN DEPUY ACS 28MM LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 10, 2010
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·September 3, 2024
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
FDA Recall
Terminated
·Intersurgical Inc·Product code CAI·April 25, 2018
Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
FDA Recall
Terminated
·Galil Medical·Product code GEH·November 11, 2010
Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
FDA Recall
Terminated
·Heart Sync, Inc·Product code MLN·December 5, 2008
Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
FDA Recall
Terminated
·Heart Sync, Inc·Product code MLN·December 5, 2008
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
FDA Recall
Open, Classified
·Intersurgical Inc·Product code CCW·June 17, 2025
Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb, Incorporated, Rochester, NY 14609. Product is used for For the cleaning, rinsing, disinfecting, and storage of soft contact lenses.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code LPN·August 17, 2009
Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code LPN·June 30, 2009
Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.
FDA Recall
Terminated
·Therakos Inc·Product code LNR·February 1, 2011
VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CEM·May 9, 2013
The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.
FDA Recall
Terminated
·Intersurgical Inc·Product code BSF·February 9, 2011
NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of ThermoFisher Scientific
FDA Recall
Terminated
·Lab Vision Corporation·Product code NJT·March 5, 2010