16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ATOMLIGHT (LIQUID SCINTILLATION SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACUMED
FDA UDI
Acumed LLC·10806378047848·Universal Plate Cutting Jaw 01 Assy
3T L. V. CONTROL VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRASEAL ID
FDA 510(k)
FDA Class 2
·Dental
STAT DL 10.5 FR. 50 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 27, 1998
ECLIPSE TRUNION 43MM, SLOTTED, TPS CAP
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code QHQ·February 8, 2024
ECLIPSE SHOULDER PROSTHESIS
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code QHQ·February 8, 2024
UNIVERS VAULTLOCK GLENOID, SMALL
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code KWS·January 3, 2024
ARTHREX ECLIPSE HUMERAL HEAD, 43/16
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code QHQ·January 3, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 17, 2012
HARMONIC ACE 23CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 16, 2010
EQUINOXE REVERSE 38MM GLENOSPHERE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 18, 2023
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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