12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124788·Modular Stem 15mm x 125mm
R1 shock-proof black, 1-tube, disinfectable one-piece cuff, obese size
FDA UDI
Rudolf Riester GmbH·04045396178458·Aneroid sphygmomanometers for non invasive meas...
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK
PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
The Octane Straight Intervertebral Fusion Device, Ti Coated
FDA 510(k)
FDA Class 2
·Orthopedic
PRSVN ALLPOLY TIB RMLL S2 7MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code HRY·September 15, 2011
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013