10 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Reprocessed Tri Pulse Compression Garment

FDA 510(k)
FDA Class 2 ·Cardiovascular

Ophthalmic Spatulas

FDA UDI
KATENA PRODUCTS, INC.·00841668114322·RUBENSTEIN CORNEAL ROLLER (BX/3)

Ophthalmic Hooks

FDA UDI
KATENA PRODUCTS, INC.·00841668114315·PUSH-PULL HOOK ANGLED (BX/3)

HEMO-STREAM HEMODIALYSIS CATHETER SET

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

MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 27, 2014

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

TPS UNIVERSAL DRIVER

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·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