14 results · 24ms · Sources: EU EUDAMED, 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