9 results · 19ms · Sources: EU EUDAMED, US FDA

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NOA Sleep Apnea and Snoring Device

FDA 510(k)
FDA Class 2 ·Dental

Cal OSHA - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal

C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET

FDA 510(k)
FDA Class 2 ·Immunology

HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT

FDA 510(k)
FDA Class 2 ·Orthopedic

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 8, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·July 10, 2024

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