33 results · 23ms · Sources: EU EUDAMED, 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