45 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Aesculap PAS-Port Proximal Anastomosis System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
C6 Sensor 3.0, Rebuilt
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C6R30·
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112830·BARRON VACUUM PUNCH 9.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM
SprintRay OnX Tough 2 - A2 - 500g
FDA UDI
Sprintray, Inc.·00850039704598·SprintRay OnX Tough 2 is a tooth shade ceramic-...
Marking Pen
FDA UDI
KATENA PRODUCTS, INC.·00841668113219·MARKING PEN FOR TREPHINE & PUNCH
GALEMED PEAK FLOW METER, MODELS 3751/3752
FDA 510(k)
FDA Class 2
·Anesthesiology
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VITEK MS INSTRUMENT - 410895
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code QBN·October 29, 2021
LARGE OPEN POLY SCREW 4.5MM X 25MM
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code KWP·October 16, 2008
FITMORE HIP STEM B EXT. OFFS. SIZE 7
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·June 18, 2013
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
AMPLATZER AMULET
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NGV·May 30, 2024
Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
ACCUTRAK DELIVERY CATHETER SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 17, 2021
TEOSYAL RHA 2
FDA Adverse Event
Injury
·TEOXANE SA·Product code LMH·March 25, 2021
FILMARRAY® PNEUMONIA PANEL PLUS
FDA Adverse Event
Injury
·BIOFIRE DIAGNOSTICS, LLC·Product code QDS·March 13, 2025
FILMARRAY® PNEUMONIA PANEL PLUS
FDA Adverse Event
Injury
·BIOFIRE DIAGNOSTICS, LLC·Product code QDS·March 13, 2025
630G INSULIN PUMP MMT-1715K 630G BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·January 6, 2022
RHA2
FDA Adverse Event
Injury
·TEOXANE·Product code LMH·March 18, 2021