112 results · 22ms · Sources: EU EUDAMED, US FDA

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RAZOR Single-Use Acetabular Reamer

FDA UDI
Razor Medical Instruments, Inc.·00850022768002·Acetabular Orthopedic Reamer, 46mm

Intubation Guide Kit

FDA UDI
Nar Medical Depot, LLC·00860009615533·AIR Q KIT - SZ 3

Haas Expander

FDA UDI
ALLESEE AOA-PRO·00889989038705·Haas Expander

INSTRUMENT

FDA UDI
Howmedica Osteonics Corp.·07613327014464·PATELLA CUTTER

Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·May 10, 2023

ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 19, 2023

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·STAARVISC II

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

X3 TRIATHLON CS INSERT #6 9MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·September 3, 2014

CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DYB·May 3, 2022

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 19, 2024

640G INSULIN PUMP MMT-1710K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 27, 2020

ARCH KOH-EFFICIENT

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code HEW·February 19, 2025

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·COEASE SODIUM HYALURONATE

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·ALPHA I INFLATABLE PENILE PROSTHESIS