14 results · 32ms · Sources: EU EUDAMED, 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