18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OPTICAL FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9360041·Inner Matrix, green, standard
LP Low Profile
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746091100·DB BKT LP V-SLOT UL LAT 018 T+8 A+9 R=0
SeaSpine® Spacer System - Redondo
FDA UDI
Seaspine Orthopedics Corporation·10889981091200·Inserter Head, 12mm Implant
ENDOSCOPE AND ACCOSSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESCORT 100/300 SERIES B PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Zimmer, Inc.·00889024078239·
NA
FDA UDI
Zimmer, Inc.·00889024104051·
NA
FDA UDI
Zimmer, Inc.·00889024104037·
NA
FDA UDI
Zimmer, Inc.·00889024078222·
NA
FDA UDI
Zimmer, Inc.·00889024104044·
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 30, 2013
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code LQC·December 22, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·July 15, 2014
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 5, 2012
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 5, 2012