Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Media, Reproductive

FDA product code MQL · 248 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.6180
Review panel: OB
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1987-02-02 – 2026-08-28

MQL 2000-05-16

SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

Applicant Vitrolife AB/Scandinavian Ivf Sciences AB

K number K000621

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MQL 2000-05-09

MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079

Applicant Medicult A/S

K number K991472

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MQL 2000-05-09

MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)

Applicant Medicult A/S

K number K991471

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MQL 2000-05-04

MEDI-CULT SPERM PREPARATION - MEDIUM;

Applicant Medicult A/S

K number K991332

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MQL 2000-05-04

MEDI-CULT FLUSHING MEDIUM

Applicant Medicult A/S

K number K991327

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MQL 2000-05-04

HUMAN SERUM ALBUMIN (HSA)

Applicant Invitrocare, Inc.

K number K000940

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MQL 2000-05-04

HTF-HEPES

Applicant Invitrocare, Inc.

K number K000939

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MQL 2000-04-19

OIL FOR TISSUE CULTURE

Applicant Advanced Reproductive Technologies

K number K991380

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MQL 2000-03-13

BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM

Applicant Irvine Scientific Sales Co., Inc.

K number K000309

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MQL 2000-03-07

MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)

Applicant Medicult A/S

K number K991470

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MQL 2000-02-28

MEDI-CULT FREEZING & THAWING PACKS

Applicant Medicult A/S

K number K991335

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MQL 2000-02-28

MEDI-CULT SPERM FREEZE MEDIUM

Applicant Medicult A/S

K number K991333

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MQL 2000-02-25

OVOIL-150, MODEL 5002

Applicant Vitrolife Sweden AB

K number K991351

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MQL 2000-02-25

MEDI-CULT LIQUID PARAFFIN

Applicant Medicult A/S

K number K991330

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MQL 2000-02-25

MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE

Applicant Medicult A/S

K number K991329

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MQL 2000-02-24

PH-100, MODEL 2104

Applicant Vitrolife Sweden AB

K number K991346

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MQL 2000-02-18

ASP-100, MODEL 2100

Applicant Vitrolife Sweden AB

K number K991345

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MQL 2000-02-15

WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L

Applicant Sage Biopharma

K number K991396

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MQL 2000-02-15

QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM

Applicant Advanced Reproductive Technologies

K number K991395

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MQL 2000-02-07

HUMAN SERUM ALBUMIN

Applicant Advanced Reproductive Technologies

K number K991392

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MQL 2000-02-02

HYALURONIDASE, 80 U/ML

Applicant Sage Biopharma

K number K991393

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MQL 2000-02-02

QUINN'S SPERM WASHING MEDIUM

Applicant Advanced Reproductive Technologies

K number K991379

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MQL 2000-01-18

1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI

Applicant Sage Biopharma

K number K991390

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MQL 2000-01-10

PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF

Applicant Advanced Reproductive Technologies

K number K991391

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MQL 1999-12-06

TYRODE'S SOLUTION-ACIDIFIED

Applicant Irvine Scientific Sales Co., Inc.

K number K991339

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MQL 1999-09-24

PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA

Applicant Pacific Andrology, Inc.

K number K991381

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MQL 1999-09-24

PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED

Applicant Sage Biopharma

K number K991378

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MQL 1999-09-14

MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI

Applicant Irvine Scientific Sales Co., Inc.

K number K991419

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MQL 1999-09-09

<GENX> SPERM WASHING MEDIA

Applicant <Genx> Intl., Inc.

K number K991022

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MQL 1999-07-26

ENHANCE-S PLUS

Applicant Conception Technology, Inc.

K number K991322

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MQL 1999-07-19

<GENX> FERTILIZATION MEDIA-HTF

Applicant <Genx> Intl., Inc.

K number K991173

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MQL 1999-07-14

PVP (POLYVINYLPYRROLIDONE)

Applicant Irvine Scientific Sales Co., Inc.

K number K991343

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MQL 1999-07-14

BOVINE SERUM ALBUMIN (BSA)

Applicant Irvine Scientific Sales Co., Inc.

K number K991338

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MQL 1999-07-08

PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION

Applicant Irvine Scientific Sales Co., Inc.

K number K991342

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MQL 1999-07-08

ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION

Applicant Irvine Scientific Sales Co., Inc.

K number K991341

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MQL 1999-07-08

SPERM MAINTENANCE MEDIUM WITH GLYCEROL

Applicant Irvine Scientific Sales Co., Inc.

K number K991337

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MQL 1999-07-02

FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)

Applicant Irvine Scientific Sales Co., Inc.

K number K991421

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MQL 1999-07-02

MODIFIED HAM'S F-10 WITH ALBUMIN

Applicant Irvine Scientific Sales Co., Inc.

K number K991420

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MQL 1999-04-26

SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM

Applicant Irvine Scientific Sales Co., Inc.

K number K983588

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MQL 1999-04-23

SYNTHETIC SERUM SUBSTITUTE (SSS)

Applicant Irvine Scientific Sales Co., Inc.

K number K983579

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MQL 1999-02-18

P-1 (PREIMPLANTATION STAGE ONE) MEDIUM

Applicant Irvine Scientific Sales Co., Inc.

K number K983589

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MQL 1999-02-18

HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI

Applicant Irvine Scientific Sales Co., Inc.

K number K983586

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MQL 1999-02-18

BLASTOCYST MEDIUM

Applicant Irvine Scientific Sales Co., Inc.

K number K983580

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MQL 1999-02-08

HUMAN SERUM ALBUMIN (HSA)

Applicant Irvine Scientific Sales Co., Inc.

K number K983584

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MQL 1999-01-14

MODIFICATION OF PURESPERM

Applicant Nidacon International AB

K number K984172

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MQL 1998-06-23

PURESPERM

Applicant Nidacon International AB

K number K980814

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MQL 1997-07-03

ISOLATE

Applicant Irvine Scientific Sales Co., Inc.

K number K971809

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MQL 1987-02-02

SPERM SELECT(TM)

Applicant Pharmacia, Inc.

K number K864524

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