19 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Temno Elite Biopsy System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433866·Integra® Jarit® Kelly Retractor, 10", Hollow Gr...
24M - Nevada Energy - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113998·HYDRO-DISSECT CANNULA VERTICAL 27GA
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992011660·LIPOSUCTION CANNULA COBRA
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450156537·
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRA V THERAPEUTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 10, 2015
BD ANGIOCATH¿ PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·October 2, 2018
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·January 21, 2016
ALARIS® PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·April 17, 2017
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·April 8, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 29, 2011
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021