14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sonio Detect
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517630414·CoRoent Ant TLIF Ti, 13x10x36mm 15°
EarQ
FDA UDI
Sbo Hearing A/S·05714464029952·EARQ F40 MINIRITE T C092
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")
GELPI SPINAL RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026551·GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED C...
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
FDA 510(k)
FDA Class 2
·Orthopedic
DEROYAL DRAPES, STERILE, NON-STERILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·November 7, 2008
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 1, 2011
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 16, 2013
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014