11 results
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19ms
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Sources: EU EUDAMED, US FDA
KASIOS TCP
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809872385·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
FDA 510(k)
FDA Class 1
·General Hospital
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PENUMA IMPLANT
FDA Adverse Event
Injury
·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018
12.4 CM HEAVY DUTY LONG ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 3, 2013
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011
CONTAK RENEWAL 3 RF HE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
ACCUVUE ADVANCE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 19, 2007
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labels left and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual
FDA Enforcement
Class II
·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026