10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Actively Trying Personal Lubricant Rose Scented
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Bernafon
FDA UDI
Bernafon AG·05711584115015·CZ7 MNR T R, 2.4G NFM MSIL/MAC CORAL 7 GPL
NEUROMOVE NM900
FDA 510(k)
FDA Class 2
·Physical Medicine
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·July 12, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·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
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017