11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Electric breast pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Bernafon
FDA UDI
Bernafon AG·05711584115008·CZ7 MNR T R, 2.4G NFM SABE/MSIL CORAL 7 GPL
SR-1 Skin Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DILATING TIP OBTURATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
LIFEBAND® LOAD-DISTRIBUTING BAND
FDA Adverse Event
Injury
·ZOLL CIRCULATION, INC.·Product code DRM·July 9, 2025
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
RADIAL JAW¿ 4
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·August 16, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 9, 2013
HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes
FDA Enforcement
Class II
·Terminated·HemoCue AB·November 6, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023