11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00887709018235·100" (254 cm) Appx 12.4 mL, 15 Drop 24 Hour Adm...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196433·AK3 Tibial Instruments Pan
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690195146·AK3 Tibial Instruments Pan Insert
247
FDA UDI
SUNTECH MEDICAL, INC.·10840935105657·
BriefCase
FDA 510(k)
FDA Class 2
·Radiology
ANALYZER, IMPACT 200
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HANSSON TWIN HOOK 90MM, OMEGA PLUS TI
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-SELZACH·Product code LXH·March 5, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
ADAPTA DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·August 7, 2014