21 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502341·OPEN MR-INDICATOR
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040303·DONUT PESSARY #3
ImarC™
FDA UDI
Carbon Medical Technologies, Inc.·00858015005479·Tissue Marker System - Core Delivery
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502969·OPEN MR-INDICATOR - PLATE HOLDER
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503126·OPEN MR-INDICATOR - PLATE LEFT
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502952·OPEN MR-INDICATOR - PLATE RIGHT
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101116·SS Suture, 3 per sleeve
VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBH·December 16, 2016
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
FDA 510(k)
FDA Class 2
·Cardiovascular
ATS 750 TOURNIQUET SYSTEM (ENGLISH)
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code KCY·April 3, 2013
PENUMBRA COIL 400 DETACHMENT HANDLE
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·February 15, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·May 7, 2008
LAP SPONGES
FDA Adverse Event
JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD.·Product code GDY·October 29, 2015
PF-VIRTEC SYSTEM CMTED LAT.6
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·August 6, 2019
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·September 27, 2011
Precision PCx Test Strips Part Number: 98757-12
FDA Recall
Terminated
·Abbott Laboratories, Inc.·Product code CGA·November 8, 2002
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018