21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SENOGRAPHIC STEREO
FDA 510(k)
FDA Class 2
·Radiology
Leksell Vantage Stereotactic System
FDA UDI
Elekta Solutions AB·07340201501948·ARC SLIDE RIGHT
DD Bio Splint P HI
FDA UDI
Dental Direkt GmbH·EDDIK401251·DD medical polymers (PMMA), made from PMMA, are...
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496040125·MISS RELAX MICRO RETE 70 SHEER, SIZE S, SABBIA,...
Arthrex®
FDA UDI
ARTHREX, INC.·00888867522121·Cannulated Cancellous Screw, 7.0x125mm
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 125mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009897·
Toilet Support Arms
FDA UDI
Ropox A/S·05707581000294·
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
JET PORT PLUS CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
CADD
FDA UDI
ICU MEDICAL, INC.·10610586045387·
CADD
FDA UDI
ICU MEDICAL, INC.·10610586044168·
C & B FORMULA
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400401250·C & B FORMULA 1 OZ SHADE 25
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 3, 2013
ATN LAG SCREW 105MM STERILE
FDA Adverse Event
Injury
·DEPUY ACE S.A. 'R.L.·Product code HSB·May 7, 2008
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 5, 2011
McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
FDA Recall
Terminated
·Product code FTR·September 12, 2003
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
ULTRA 2 CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016