Vitrolife Sweden AB is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Vitrolife Sweden AB - FDA 510(k) Cleared Devices
Recent clearances: Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500), Ultrasound Transducer Cover, Ultra RapidWarm™ Blast
38
Total
38
Cleared
0
Denied
Vitrolife Sweden AB has 38 FDA 510(k) cleared obstetrics & gynecology devices. Based in Ringoes, US.
Latest FDA clearance: Jul 2025. Active since 2000.
Browse the complete list of FDA 510(k) cleared obstetrics & gynecology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Regulatory Specialists, Inc. and Regulatory Specialist, Inc..
FDA 510(k) Regulatory Record - Vitrolife Sweden AB
38 devices
Cleared
Jul 23, 2025
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer...
Obstetrics & Gynecology
266d
Cleared
Aug 30, 2024
Ultrasound Transducer Cover
Radiology
81d
Cleared
Aug 07, 2024
Ultra RapidWarm™ Blast
Obstetrics & Gynecology
156d
Cleared
May 14, 2021
Gx-IVF, Gx-TL, Gx-MOPS PLUS
Obstetrics & Gynecology
228d
Cleared
Jul 26, 2019
RapidVit™ Oocyte, RapidWarm™ Oocyte
Obstetrics & Gynecology
221d
Cleared
Jan 04, 2019
Rapid-i™ Kit
Obstetrics & Gynecology
214d
Cleared
Nov 21, 2017
Follicle Aspiration Set, Reduced Single Lumen
Obstetrics & Gynecology
138d
Cleared
Jun 14, 2017
Follicle Aspiration Set
Obstetrics & Gynecology
331d
Cleared
Dec 21, 2015
FreezeKit Cleave , ThawKit Cleave
Obstetrics & Gynecology
257d
Cleared
Dec 18, 2014
RAPID-I KIT
Obstetrics & Gynecology
324d
Cleared
Oct 26, 2012
SPERMFREEZE SOLUTION
Obstetrics & Gynecology
309d
Cleared
Dec 10, 2010
RAPIDVIT BLAST, RAPIDWARM BLAST
Obstetrics & Gynecology
242d
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