13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304002364·
Bio-Modular® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868253621·
5530 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021812·3L MASTER SYRINGE 6 NIST CALS
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105223·PS3 Screw 7.5mm x 60mm
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
FDA 510(k)
FDA Class 2
·Cardiovascular
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
SORIN C5 SYSTEM WITH MAST ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWB·May 21, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 17, 2014
SHILEY PEDIATRIC
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO·Product code JOH·June 2, 2011
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025