16 results · 26ms · Sources: EU EUDAMED, US FDA

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FREHAN INC. I.V. FILTER HOLDER

FDA 510(k)
FDA Class 1 ·General Hospital

NA

FDA UDI
LANCER ORTHODONTICS, INC.·00817573023936·CERVICAL STRAP NYLON W/MODULE 1/PK

Auria™ T-Mic™

FDA UDI
Advanced Bionics, LLC·07630016808593·Beige

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932243·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930041·Percutaneous Transluminal Angioplasty Balloon C...

Auria™ T-Mic™

FDA UDI
Advanced Bionics, LLC·00840094450554·Beige

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955931147·Percutaneous Transluminal Angioplasty Balloon C...

OPAQUE HERRICK LACRIMAL PLUG

FDA 510(k)
FDA Unclassified ·Unknown

HEATER-COOLER UNIT HCU 40

FDA 510(k)
FDA Class 2 ·Cardiovascular

UniTip Catheter

FDA UDI
Unisensor AG·07640172971666·

HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 23, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 13, 2012

ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 5MM DIAMTER, 150MM LENGTH

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GCJ·January 2, 2008

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020