19 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMART TOUCH UVTHERAPY MULTIPLE MACHINE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989028645·COPPER NITI 27 BAF 16X22L/L PK10
INTREPED, Intraosseous Fusion Device
FDA UDI
Auxano Medical LLC·00850055649507·INTREPED 09x12 implant
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321109120·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311109120·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K1190120·Tray Insert 4, Cosmo MIS, Arcamed
AincA®
FDA UDI
ANESTHESIA ASSOCIATES, INC.·B005AAS1109120·Breathing Tube, 22mmM x 22mmF, Polyester/Silico...
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
FDA 510(k)
FDA Class 2
·Neurology
ALARMVIEW WIRELESS DATA NETWORK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VUE PACS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 4, 2020
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·June 2, 2011
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
FDA Enforcement
Class II
·Terminated·Biocare Medical, LLC·May 6, 2015
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
FDA Enforcement
Class II
·Terminated·ConMed Corporation·May 22, 2013
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024