18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFE SPINE STAND-ALONE SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489112815·TrueForm Nitrile Exam Gloves, Extra Small
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138125186·SUSPENSORY SUPPORT W/ LEG STRAPS SMALL
LEONE SPA
FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482053140·Symmetry® Probe, Sinus Bayonet, Straight, Beade...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450400920·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450388921·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450391402·
ZOLL CABLE
FDA UDI
Zoll Medical Corporation·00847946016753·
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
20/30 PRIORITY PACK W/COPILOT
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAV·December 18, 2014
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 14, 2014
V SERIES MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 20, 2011
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025