33 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
FDA 510(k)
FDA Class 2
·Dental
VACCESS LT LONG-TERM HEMODIALYSIS CATHETER
FDA UDI
Bard Access Systems, Inc.·00801741010651·VACCESS ST, 14.5 FR. 19cm
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551146452·ALLEN WRENCH FOR MODEL 2103-188 AND 2103-189 DE...
SONTEC I.M. PIN KEYED DRILL CHUCK
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896052086·SONTEC I.M. PIN KEYED DRILL CHUCK 3/8 INCH STAI...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114148·SIMCOE I/A SYSTEM 23GA (PK/3)
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551001300·ALLEN WRENCH FOR MODEL 2103-188 AND 2103-189 DE...
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 29, 2020
EN BLOC BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025
BLAKE DRAIN
FDA Adverse Event
Malfunction
·ETHICON·Product code KOG·May 12, 2011
GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·May 9, 2013
INTRACLUDE AORTIC OCCLUSION DEVICE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DXC·September 19, 2014
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 25, 2011
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·June 14, 2017
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 10, 2021