14 results · 20ms · Sources: EU EUDAMED, US FDA

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IMMULITE® 2000 Cortisol

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)

Tissue Holder

FDA UDI
KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A202826150·20mm H x 28mm W x 26mm L x 15 degrees

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A202826120·20mm H x 28mm W x 26mm L x 12 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A20282680·20mm H x 28mm W x 26mm L x 8 degrees ALIF

EQUITY

FDA 510(k)
FDA Class 2 ·Dental

CLEAR-IT ANTI-FOG, MODEL PS003

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

UNK

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 17, 2008

ATLANTIS¿ SR PRO²

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT·Product code DQO·August 11, 2011

ACCU-CHEK ® AVIVA PLUS TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 2, 2013

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

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