33 results · 21ms · Sources: EU EUDAMED, 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