14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Aglaia LED Beauty Device (BP-D2309)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813057759·STERILE CARBIDE BUR RA4
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812446·Vu-Mar XL Speculum - Pederson, Medium, 10cm x 2...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250413200·ceraMotion® PZr Press Liner C4, 20 g / dental c...
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
FDA 510(k)
FDA Class 2
·Physical Medicine
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
FDA 510(k)
FDA Class 2
·Cardiovascular
IMP,TSV,4.1MM,SBM,11.5
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 23, 2024
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 3, 2008
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·September 15, 2011
UNKNOWN MALLORY-HEAD STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·July 26, 2013
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020