12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ULTRASONIC MESH NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
A BAER WITH ABAER I/O FUNCTION
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INFLATOR KIT 18INFKIT BALLOON
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014
BALLOON SEEKER
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·October 1, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 29, 2013
ONDASPACE EXTENSION ARM
FDA Adverse Event
Malfunction
·STRYKER COMMUNICATIONS·Product code BRY·June 10, 2011
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·February 5, 2014
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZE·January 6, 2014
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015