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

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Dental Scaler and Air Polisher

FDA 510(k)
FDA Class 2 ·Dental

n.a.

FDA UDI
Karl Storz GmbH & Co. KG·04048551067079·Suction Tube, outer diameter 1.5 mm

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113868·ROBINS ANTERIOR CHAMBER CANNULA, 30GA

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114186·KRATZ POLISHER 21GA SIDE (PK/10)

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

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

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS

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

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 27, 2014

CAPSUREFIX NOVUS MRI

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

MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code MAF·July 3, 2013

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

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018