129 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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HEEL SNUGGLER, MODEL 99047
FDA 510(k)
FDA Class 1
·Physical Medicine
Viking™ L mobile lift
FDA UDI
Liko AB·00887761981867·Mobile patient lifting system, battery-powered
Leksell Vantage Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502242·CT TABLE FIXATION TOSHIBA
OneFill
FDA UDI
US ENDODONTICS, LLC·00810047644637·Endodontic Verifier
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100440·Assembly, Caddie, Locking Caps
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0100440·Caddie, Locking Caps
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420400440·Anterio Lateral Closing Wedge Osteotomy Guide, ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410400440·Anterior Closing Wedge Osteotomy Guide, 40mm x ...
NA
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311022·
HOMMED SENTRY III PATIENT MONITOR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MATRIX VASCULAR CLOSURE SYSTEM (VSG)
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift - Product Code 2040006; 6) Viking XS Mobile Lift - Product Code 2040007; 7) LikoLight Mobile lift - Product Code 2030001. .
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 16, 2025
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 8, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·March 25, 2011
INDURA CATHETER
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·May 7, 2008
NON-VENTED HOSPITAL FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·April 26, 2017
ANSPACH INTEGRATION PACKAGING ASSEMBLY
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 19, 2019
UPS ASSY
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 19, 2019
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNX VASCULAR CLOSURE DEVICE