22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Yomi Robotic System
FDA 510(k)
FDA Class 2
·Dental
Impact™
FDA UDI
B BRAUN INTERVENTIONAL SYSTEMS, INC·04046964291326·IMPACT 22MMX2CMX75CM
Medline-Microtek
FDA UDI
Microtek Medical LLC·00748426142125·Phelan Table Cover, 142 cm x 216 cm (56 in x 85...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021227·FPS 2.7mm x 50mm Locking Screw
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657006538·Weil Blakesley Forceps, size 00, 45 degree, 3 x...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111189920·QUIMBY GUM SCISSORS STR 5"
Bi-Lens BillBoard
FDA UDI
Paragon Vision Sciences, Inc.·B222750·The Bi-Lens Billboard Case base is fabricated ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075589·FPS 2.7 x 50mm Locking Screw Sterile Qty 2
Knee+
FDA 510(k)
FDA Class 2
·Neurology
PLV CONTINUUM VENTILATOR, MODEL P1000
FDA 510(k)
FDA Class 2
·Anesthesiology
WALLSTENT¿ BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 25, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
VA-LCP PROX ULNA PL 2.7/3.5 R 10HO L184
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·July 12, 2013
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·November 26, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·July 22, 2025
ALINITY I HAVAB-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·June 25, 2025
ALINITY I HAVAB-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·June 25, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·January 23, 2026
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·January 16, 2026
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018