13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL DESIGN CIRCUMCISION CLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
U.S. ORTHOTICS, INC.
FDA registration
U.S. ORTHOTICS, INC.·12 products·🇺🇸 United States
EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
FDA 510(k)
FDA Class 2
·Cardiovascular
CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
FDA 510(k)
FDA Class 2
·General Hospital
CARDIOMEMS PATIENT ELECTRONIC SYSTEM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code MOM·March 7, 2024
ECHO POR FEM RED LAT NC
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 7, 2021
BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·February 21, 2025
LIGACLIP** CLIP APPLIER - SMALL - 19 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·April 9, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·March 28, 2011
ACUITY STEERABLE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 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