33 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SpheRx
FDA UDI
Nuvasive, Inc.·00887517813695·SpheRx II Gearshift Probe, Straight
Bernafon
FDA UDI
Sbo Hearing A/S·05714464056675·BERNAFON ALPHA 3 MNR T MAC/MSIL
devemed
FDA UDI
devemed GmbH·04061644017171·Caliper "Castroviejo" | 9 cm
straight / 0-20 mm
Reicodent
FDA UDI
devemed GmbH·04061644049868·Caliper "Castroviejo" | 9 cm
straight / 0-20 mm
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODULAR RADIAL HEAD REPLACEMENT DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code FZP·August 18, 2015
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code FZP·August 18, 2015
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·July 9, 2024
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·July 9, 2024
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·July 9, 2024
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·July 9, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 22, 2013
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
FDA Enforcement
Class II
·Ongoing·HUMAN MED AG·March 12, 2025
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020