16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
Radifocus Glidewire Endoscopic Wire
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088071·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962101995·ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 2.9mm x...
CARDIODAY
FDA 510(k)
FDA Class 2
·Cardiovascular
AXLE INTERSPINOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104200·ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 2.9mm x...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 26, 2024
AMISTEM COLLARED HA COATED STD STEM SIZE 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 16, 2018
ORS-320N SOLUTION WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·June 22, 2016
LAMITRODE TRIPOLE 16
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 3, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 6, 2011
GIA 80-3.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·September 5, 2008
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020