Medical Device Manufacturer · US , Ringoes , NJ

Vitrolife Sweden AB

38 submissions · 38 cleared · Since 2000
38
Total
38
Cleared
0
Denied

Vitrolife Sweden AB — FDA 510(k) Submissions

Vitrolife Sweden AB has submitted 38 FDA 510(k) premarket notifications since 2000, of which 38 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Media, Reproductive, Needle, Assisted Reproduction, Labware, Assisted Reproduction, System And Accessories, Isolated Heart, Transport And Preservation, Transducer, Ultrasonic, Diagnostic . Use the specialty filter in the sidebar to narrow results.

38 devices
1–25 of 38
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
K243373 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Jul 2025 266d
Ultrasound Transducer Cover
K241662 · ITX Transducer, Ultrasonic,... · Radiology
Aug 2024 81d
Ultra RapidWarm? Blast
K240605 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2024 156d
Gx-IVF, Gx-TL, Gx-MOPS PLUS
K202862 · MQL Media, Reproductive · Obstetrics & Gynecology
May 2021 228d
RapidVit? Oocyte, RapidWarm? Oocyte
K183486 · MQL Media, Reproductive · Obstetrics & Gynecology
Jul 2019 221d
Rapid-i? Kit
K181461 · MQK Labware, Assisted... · Obstetrics & Gynecology
Jan 2019 214d
Follicle Aspiration Set, Reduced Single Lumen
K172050 · MQE Needle, Assisted... · Obstetrics & Gynecology
Nov 2017 138d
Follicle Aspiration Set
K161970 · MQE Needle, Assisted... · Obstetrics & Gynecology
Jun 2017 331d
FreezeKit Cleave , ThawKit Cleave
K150950 · MQL Media, Reproductive · Obstetrics & Gynecology
Dec 2015 257d
RAPID-I KIT
K140207 · MQK Labware, Assisted... · Obstetrics & Gynecology
Dec 2014 324d
SPERMFREEZE SOLUTION
K113786 · MQL Media, Reproductive · Obstetrics & Gynecology
Oct 2012 309d
RAPIDVIT BLAST, RAPIDWARM BLAST
K101003 · MQL Media, Reproductive · Obstetrics & Gynecology
Dec 2010 242d
RAPID-I
K090832 · MQK Labware, Assisted... · Obstetrics & Gynecology
Dec 2009 272d
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727 · MQE Needle, Assisted... · Obstetrics & Gynecology
Feb 2009 142d
RAPIDVIT AND RAPIDWARM CLEAVE
K080446 · MQL Media, Reproductive · Obstetrics & Gynecology
Nov 2008 281d
PERFADEX WITH THAM
K081997 · MSB System And Accessories,... · Gastroenterology & Urology
Oct 2008 87d
G-MOPS G5 SERIES
K081115 · MQL Media, Reproductive · Obstetrics & Gynecology
Sep 2008 152d
G-1 V5
K081114 · MQL Media, Reproductive · Obstetrics & Gynecology
Sep 2008 151d
G-2 V5
K081117 · MQL Media, Reproductive · Obstetrics & Gynecology
Sep 2008 151d
G-IVF G5 SERIES
K081116 · MQL Media, Reproductive · Obstetrics & Gynecology
Sep 2008 137d
ICSI-100
K043116 · MQL Media, Reproductive · Obstetrics & Gynecology
Jan 2005 64d
G-OOCYTE
K032877 · MQL Media, Reproductive · Obstetrics & Gynecology
May 2004 235d
G-PGD
K033101 · MQL Media, Reproductive · Obstetrics & Gynecology
May 2004 221d
EMBRYOGLUE
K031015 · MQL Media, Reproductive · Obstetrics & Gynecology
Jun 2003 84d
SPERMGRAD, MODELS 10022/10063
K023403 · MQL Media, Reproductive · Obstetrics & Gynecology
Dec 2002 64d
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