12 results
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18ms
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Sources: EU EUDAMED, US FDA
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