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

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RANDOX DIGOXIN

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

IMPACT-PLUS

FDA UDI
Denplus Inc·D8451011302·IMPACT-PLUS,LPL, 11.3 kg

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040047507·Scaler Jacquette DE 31/32

NVJJB

FDA UDI
Nuvasive, Inc.·00887517164933·NV RM Network Cable, NVJJB IOM

MASEL

FDA UDI
Ortho Organizers, Inc.·00190707053765·GeoShapes™ Elastics 3/16" (4.76 mm) Medium 3.5o...

Ovation Tribute Hip Stem

FDA UDI
Ortho Development Corporation·00822409011230·EXT SIZE 2 Stem Plasma Spray

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0112020·Tap, 4.75mm

Canaveral®

FDA UDI
FLOSPINE LLC·B183113020010·Modular Open Polyaxial Headbody Extended Tab As...

ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NANOSCOPE HANDPIECE

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code GCJ·May 14, 2024

SYNCHRON LXI 725 CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·November 15, 2011

SYNCHRON LXI 725 CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·November 15, 2011

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·March 19, 2013

TOTAL ASR ACET IMP SIZE 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·March 4, 2011

ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 11, 2008

PROCLEIX WEST NILE VIRUS ASSAY

FDA Adverse Event
GEN-PROBE·Product code NOP·March 25, 2005

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

FDA Enforcement
Class II ·Ongoing·Micromed S.p.A.·June 17, 2026

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012