FDA.reportPublic FDA data

Vitrolife Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20318243002757762Vitrolife Inc.1Y2026-01-014940 Carroll Canyon Rd Ste 100 San Diego CA US 92121
30032740903003274090Vitrolife Inc.1Y2026-01-013601 South Inca Street Englewood CO US 80110
30038439273003843927Vitrolife GmbH1N2026-01-01Roedersteinstrasse 6 Landshut Bavaria DE 84034
30039959323003995932VITROLIFE SWEDEN AB1N2026-01-01Gustaf Werners Gata 2 Vastra Frolunda Vastra Gotaland SE SE-421 32

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1229531253113208K993140WATER FOR TISSUE CULTURE, MODELS 1500MTW2000-08-02
184031884543456K991700SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZOMQH1999-07-19
184031747130039K991351OVOIL-150, MODEL 5002MQL2000-02-25
184031623944338K991345ASP-100, MODEL 2100MQL2000-02-18
1229531782728448K991322ENHANCE-S PLUSMQL1999-07-26
184031226610361K991273SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLEMQE1999-08-18
1229531833772777K991104MICROTOOLSMQH1999-07-19
184031336441557K894490STERILE ULTRASOUND TRANSMISSION GELJOT1989-10-05
1229531753469065K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)CEP1987-07-27
184031020441454K862364NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)HEM1986-08-19
184031994196888K243373Embryo 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)MQF2025-07-23
184031701401692K241662Ultrasound Transducer CoverITX2024-08-30
184031968361632K240605Ultra RapidWarm™ BlastMQL2024-08-07
184031435005007K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSMQL2021-05-14
184032068772255K201213Pasteur Pipette 3mL, Pasteur Pipette 1mLMQK2020-12-16
667601814593792K192008LaserShot M, NaviLaseMRX2020-03-25
184031963209282K183486RapidVit™ Oocyte, RapidWarm™ OocyteMQL2019-07-26
184031978595360K181461Rapid-i™ KitMQK2019-01-04
184031473408640K172050Follicle Aspiration Set, Reduced Single LumenMQE2017-11-21
184031392011502K161970Follicle Aspiration SetMQE2017-06-14
184031637417529K150950FreezeKit Cleave , ThawKit CleaveMQL2015-12-21
184031008060616K133568G-TLMQL2014-07-16
184031648688508K101003RAPIDVIT BLAST, RAPIDWARM BLASTMQL2010-12-10
184031984543145K090832RAPID-IMQK2009-12-23
184031440398204K081117G-2 V5MQL2008-09-16
184031252259766K081116G-IVF G5 SERIESMQL2008-09-02
184031623465599K081115G-MOPS G5 SERIESMQL2008-09-17
184031951898948K081114G-1 V5MQL2008-09-16
184031170597126K080446RAPIDVIT AND RAPIDWARM CLEAVEMQL2008-11-26
184031236923733K043116ICSI-100MQL2005-01-13
184031729801137K033101G-PGDMQL2004-05-07
184031615189688K032155G-THAWKIT BLASTMQL2004-05-07
184031006257125K031015EMBRYOGLUEMQL2003-06-23
1229531574232204K030117ENHANCE SPERM FREEZEMQL2003-03-20
1229531152787100K030116ENHANCE-S PLUS HMQL2003-02-12
1229531036905112K023717SPERM WASH MEDIUM WITH GENTAMICINMQL2002-12-13
1229531354755226K023655ENHANCE HTF MEDIUM WITH HEPESMQL2002-12-13
184031320917841K023403SPERMGRAD, MODELS 10022/10063MQL2002-12-13
184031243788046K022643BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540MQH2002-11-05
184031464170195K022295G-RINSE, MODEL 10031MQL2002-09-12
184031246185177K021896HSA-SOLUTION, MODEL 10034/10064MQL2002-09-06
184031389665967K021894G-MM, MODEL 10038MQL2002-09-06
184031133027866K000627SCANDINAVIAN IVF SCIENCES AB, HYBASE-1MQL2000-06-13
184031888954048K000623SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1MQL2000-05-16
184031522511712K000621SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100MQL2000-05-16
184031016009425K000618SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1MQL2000-05-17
184031953987128
969001008060616
184031046257041
969001252259766
184031288380364
969001288380364
969001320917841
1229531354507925
969001362400525
184031373137798
969001435005007
969001440398204
969001464170195
969001522511712
969001623465599
969001623944338
969001747130039
184031800898871
969001951898948
1229531977537822
184031977537822

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQL302024-08-07
MQK32020-12-16
MQE32017-11-21
MQH32002-11-05
MQF12025-07-23
ITX12024-08-30
MRX12020-03-25
MTW12000-08-02
JOT11989-10-05
CEP11987-07-27
HEM11986-08-19

PMN#

G-TL

2014-07-16

VITROLIFE, INC.

RAPID-I

2009-12-23

VITROLIFE SWEDEN AB

G-1 V5

2008-09-16

VITROLIFE SWEDEN AB

G-2 V5

2008-09-16

VITROLIFE SWEDEN AB

G-PGD

2004-05-07

VITROLIFE SWEDEN AB

50 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next