11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Moss Gastrostomy Tube, Moss Nasal Tube Mark IV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRASHIELD 9500 SURGICAL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROTOE ENDOSORB SMALL HAMMER TOE PIN
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code ODG·June 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 16, 2014
GAMMA NAIL 11X140 DEGREE
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 28, 2011
PLUM 360¿ INFUSER
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FRN·May 16, 2024
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021