20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
FDA 510(k)
FDA Class 2
·Immunology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040140946·Maxima Gutta Percha CC 20/Vl
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810139561·Maxima Gutta Percha CC 20/Vl
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040100042·Maxima Gutta Percha CC 20/Vl
Affinity™ Heavy Body FS 36pk
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172000215·VPS Impression Material
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00193033574645·
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00196365849467·
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00193033574638·
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00196365849139·
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00193033574621·
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00196365848958·
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELLUME COVID-19 HOME TEST
FDA Adverse Event
Malfunction
·ELLUME LIMITED·Product code QKP·December 20, 2021
QUICK-CORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FCG·September 4, 2018
PROTECTA XT DR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·March 21, 2013
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
APR HIP SYSTEM ENHANCED-ACETABULAR INSERT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWB·March 14, 2008
BARD EP XT Decapolar Steerable, Product Number 201007; 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