19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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