12 results · 22ms · Sources: EU EUDAMED, US FDA

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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