29 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741026500·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674102650060·
MORRISON MEDICAL
FDA UDI
MORRISON MEDICAL, LTD·00647921102651·3X12" REUSABLE IV ARMBRD,CS/50
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383575737·Gutta Percha Points is used to root canal filin...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383534307·Gutta Percha Points is used to root canal filin...
remanium®
FDA UDI
DENTAURUM GmbH & Co.KG·J011102650000·remanium® star MD I milling blank, without bord...
Zavation
FDA UDI
Zavation LLC·00842166150522·10x26x50mm, 6°, MILC
Zavation
FDA UDI
Zavation LLC·00842166149779·10x26x50mm, 0°, MILC
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
FDA 510(k)
FDA Class 2
·Cardiovascular
COREVALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 16, 2016
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 9, 2013
PLUM XLD 110V L.A.
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 28, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code JOR·May 23, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 14, 2015
SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·April 7, 2025
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
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