44 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Premier Carvers
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783012309·CARVER CD 89/92-HF
Bur PM2-70 50K Steel Ø1.8
FDA UDI
Bien-Air Surgery SA·07630055502674·
Super Seal
FDA UDI
PHOENIX DENTAL, INC.·B1321002940·Potassium oxalate based film forming acid resis...
Mirror™
FDA UDI
CAYENNE MEDICAL, INC.·M543100294·Tibial baseplate with pegs (LM/RL-44mm)
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047075·METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE BLADE
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319736500·Knapp Iris Scissors 4" (10cm), curved, sharp-bl...
BREG
FDA UDI
BREG, INC.·00672736026724·
BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 14, 2020
MFCD 120
FDA 510(k)
FDA Class 2
·Radiology
CARESTREAM IMAGE SUITE
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 5ML SALINE FILL CHINA SP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code NGT·February 22, 2024
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013
ABBOTT M2000SP
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 16, 2011
FEM. MODULAR HEAD - M Ø32MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code LZO·April 13, 2023
Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 3, 2015
Custom Breast Augmentation Pack, part number PSS2455(D
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015