13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CLIRANS TE07 HOLLOW FIBER DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
STERICHEK TOTAL CHLORINE REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
FDA 510(k)
FDA Class 2
·Orthopedic
STAT DL 10.5 FR. 50 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 29, 1998
STAT DL 10.5 FR. 50 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 29, 1998
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 8, 2014
ADAPTER SLEEVE 11/13 +0
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
LEAD MODEL 302
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code MUZ·August 11, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024