15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743755·ACHIMED ACHILLES SUPP SAND VI
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221063106·Mini Uni-Twin(TM) Bracket APC(TM) II LR3 0T/6A ...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221094124·Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 0T/6...
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221017208·Mini Uni-Twin(TM) Bracket LR3 0T/6A .018 5/Pk
TEMP-A-SURE
FDA 510(k)
FDA Class 2
·General Hospital
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Alteon
FDA UDI
Exactech, Inc.·10885862549419·
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 30, 2007
MICROMAX-PLUS MOTOR ASSY
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·March 18, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 19, 2014
TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·September 9, 2015
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
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 2110. 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