11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lacevo Wearable Breast Pump (Model S70)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813034705·K-Type Files 25MM #15
ERBE VIO 3
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·February 4, 2026
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
U2 Total Knee System- Additional Sizes
FDA 510(k)
FDA Class 2
·Orthopedic
MAXNIBP
FDA Adverse Event
CAS MEDICAL SYSTEMS, INC.·Product code MHX·September 7, 2011
PEDIPORT 5.5MM SHORT SECONDARY PORT
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·November 25, 2008
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2013
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·November 19, 2025
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·November 19, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018