19 results · 21ms · Sources: EU EUDAMED, US FDA

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MEDISIZE RED AND MEDISIZE BLUE

FDA 510(k)
FDA Class 2 ·Anesthesiology

RUSSELL-TAYLOR

FDA UDI
Smith & Nephew, Inc.·03596010034458·TWIST DRILL FOR COLE RADIOLUCENT ...

TRESTLE LUXE

FDA UDI
ALPHATEC SPINE, INC.·00190376215273·TRESTLE LUXE II, ACP, 2-LEVEL, 46

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306815669·Richardson Retractor with Hollow Grip Handle, B...

Utrecht Interstitial Fletcher CT/MR Applicator

FDA UDI
Nucletron B.V.·08717213034341·Interstitial Ovoid (right) 20mm 15°, R10

MAX-IF1000

FDA 510(k)
FDA Class 2 ·Neurology

KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A

FDA 510(k)
FDA Class 2 ·Orthopedic

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 7, 2022

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 10, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 13, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

FDA Adverse Event
Death ·MEDTRONIC, INC.·Product code DTE·February 10, 2021

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022

MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Malfunction ·ETHICON INC.·Product code GAT·January 25, 2021

Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

Video Duodenoscope

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·June 8, 2016

Spectral CT. Computed tomography X-ray system.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 2, 2025