22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLEAN AND BOOST
FDA 510(k)
FDA Class 2
·Dental
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Unity Total Knee System
FDA UDI
CORIN LTD·05056139243912·UNITY KNEE™ PS-C INSERT - Size 6 x 20mm
Bard® Urethral Catheter
FDA UDI
C. R. Bard, Inc.·00801741029998·Bard® Tiemann Model Urethral Catheter Coude Tip
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113416·PS Insert, Size 6 x 20mm
M-Flex®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020005·Blue Silicone Tungsten Maloney Esophageal Dilat...
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·10650551093043·HEADBLOCKS, FOR USE WITH OPEN BACK HALO RINGS
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383556545·Gutta Percha Points is used to root canal filin...
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101017·Poly Insert UCCS, Size 6, 20mm
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
FDA 510(k)
FDA Class 2
·Cardiovascular
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
FDA 510(k)
FDA Class 2
·Orthopedic
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·November 29, 2012
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code DQY·July 3, 2012
ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·April 24, 2013
ADULT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 28, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·July 28, 2014
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·June 10, 2011
MICRUSFRAME18 7MM X 14.3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022
MICRUSFRAME10 7MM X 30CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022