12 results · 18ms · 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.

DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MONOBIND, INC.

FDA registration
MONOBIND, INC.·65 products·🇺🇸 United States

TCOYF FERTILITY SOFTWARE VERSION 1.0

FDA 510(k)
FDA Unclassified ·Unknown

MODIFICATION TO MIRAGE

FDA 510(k)
FDA Class 2 ·Radiology

ZYGOMATIC IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·June 26, 2024

YALE NH TT VISION SYS GBS

FDA Adverse Event
Other ·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010

ARROW - CENTRAL LINE INSERTION KIT

FDA Adverse Event
Malfunction ·TELEFLEX·Product code DQO·March 18, 2013

COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 16, 2011

TRANSCEND GUIDEWIRE

FDA Adverse Event
Injury ·NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP·Product code DQX·March 26, 2008

Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014