12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
FDA 510(k)
FDA Class 1
·Anesthesiology
NA
FDA UDI
Zimmer, Inc.·00889024156111·
N/A
FDA UDI
UTAH MEDICAL PRODUCTS, INC.·H6719026320·Cannula with 1-Way Stopcock and Cap
NA
FDA UDI
Zimmer, Inc.·00889024156128·
OXYGENATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·May 9, 2014
ATLAS PLUS VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 8, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·November 18, 2010
CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWB·February 4, 2019
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 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