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