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

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Albumin BCG2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113370·CLEAR CORNEA KNIFE 3.2MM (BX/5)

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114216·LASIK CANNULA FLATTENED 23GA

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114223·LASIK CANNULA FLATTENED 25GA

LIFESTENT LP SDS BILIARY ENDOPROSTHESIS

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

SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD INSTRUMENT MAX CLINICAL

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code OOI·September 21, 2020

THERMOPHORE AUTOMATIC MOIST HEAT PACK

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT CO.·Product code IRT·October 9, 2008

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·May 1, 2026

TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·May 5, 2016

SELEX/MAGNUM MOD HD 40MM +9

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·April 24, 2014

TI LOW PROFILE SCREW 6.5X20MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014

UNKNOWN

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014

TI LOW PROFILE SCREW 6.5X20MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014

REGEN/RNGLC+ MULTI 64MM SZ 26

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

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