13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EXTRICARE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V
Bioseal Inc.
FDA UDI
BIOSEAL·00630094013220·Stockinette Tubular 2"x72" 2ply
EP-WORKMATE WITH RPM SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
FDA 510(k)
FDA Class 1
·Clinical Toxicology
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 19, 2023
BD VACUTAINER® CITRATE TUBES 4.5 13X75 NA CITRATE (0.105M = 3.2%)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 10, 2017
BD VACUTAINER® GLASS CITRATETUBES WITH A LT. BLUE BD HEMOGARD¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2017
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code DTB·October 1, 2014
TA 60-3.5 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·June 14, 2011
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 29, 2013
CP5 FLOW MODULE
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWA·July 18, 2024
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