14 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MILAGRO INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20608301·Arch wires Titanol Budget max. .012"
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023888·BAYONETTED PUSH SCRAPER CURETTE
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862284891·LOGIC CC FEM STEM TRIAL SIZE 3 LEFT
Truliant CC
FDA UDI
Exactech, Inc.·10885862626080·TRULIANT CC MODULAR FEMORAL STEM TRIAL SIZE 3 LEFT
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HWQ·March 11, 2011
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 16, 2008
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 25, 2014
Contour¿ next GEN Blood Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024