21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASTRA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768512·GENUMEDI PSS GREEN VII
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239401·
AGXO
FDA UDI
Oticon A/S·05707131288608·H110V2, DESIGNRITE 10 WL TC AGXO
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·10842962102265·RAPIDCUT BLADE, SMALL JOINT, 2.9MM, S
ELITE IMPLANT
FDA 510(k)
FDA Class 2
·Dental
XKNIFE 5
FDA 510(k)
FDA Class 2
·Radiology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962102268·ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 3.3mm x...
X-SUIT NIR COVERED BILIARY METALLIC STENT
FDA Adverse Event
Malfunction
·MEDINOL LTD.·Product code FGE·December 27, 2017
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
EAGLE SCREW, 16MM
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code KWQ·September 5, 2008
PROLIEVE TEMPERATURE MONITOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·August 21, 2008
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026
FAST-FIX 360 CURVED NDL DELIVERY SYS
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GAT·February 10, 2026
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025
TERUMO RADIFOCUS GUIDE WIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016