Media And Components, Synthetic Cell And Tissue Culture
Hematology · 21 CFR 864.2220
Recent MDR events
5 adverse event reports on file
- WIRE TENSIONERJul 23, 2020MalfunctionSmith & Nephew, Inc.1020279-2020-03468
- 4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX 20MMNov 17, 2010MalfunctionStryker Osteosynthesis Selzach8031020-2010-00157
- DYNAMIC TUBE, BLUEFeb 8, 2006InjuryStryker Trauma Selzach8031020-2006-00004
- SYNTHESNov 17, 2004InjurySynthes Usa555528
- ALTA 4 HOLE BROAD PLATEOct 17, 2002InjuryStryker Trauma Selzach Ag8031020-2002-00008
Event type breakdown
Recalls
4 recall events for this product code
- Life Technologies, Corp.TerminatedUnknown
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Z-0171-2019 · View FDA record ↗ - Life Technologies, Corp.TerminatedUnknown
Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Z-0172-2019 · View FDA record ↗ - Life Technologies, Corp.TerminatedUnknown
Gibco Sodium Pyruvate (100 mM)
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Z-0173-2019 · View FDA record ↗ - Life Technologies, Corp.TerminatedUnknown
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Z-0174-2019 · View FDA record ↗
Registered firms
28 firms currently registered for this product code
Sartorius Biological Industries Ltd
Kibbutz Beit Haemek Northern, IL
Sterilization Services Of Virginia
RICHMOND, VA, US
Yeni Biyoteknoloji Anonim Sirketi
BALCOVA Izmir, TR
Vericel Corporation
CAMBRIDGE, MA, US
Trinity Biotech Usa
Jamestown, NY, US
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
Lonza Verviers Srl.
Verviers Liege, BE
Corin Limited
CIRENCESTER Gloucestershire, GB
Sterilization Services Of Georgia, Inc.
ATLANTA, GA, US
Expression Systems Llc.
Davis, CA, US
Legacy Biologicals
Baltimore, MD, US
Regen Lab Sa
LE MONT-SUR-LAUSANNE Vaud, CH
Irvine Scientific Llc
Santa Ana, CA, US
Aivita Biomedical, Inc.
Irvine, CA, US
Incell Corporation, Llc
SAN ANTONIO, TX, US
Himedia Laboratories Private Limited
DOMBIVLI, THANE Maharashtra, IN
Gemini Bioproducts Llc
West Sacramento, CA, US
Medikan Co., Ltd.
Gangseo-gu Seoul, KR
Himedia Laboratories Private Limited
NASHIK Maharashtra, IN
Lonza Walkersville, Inc.
WALKERSVILLE, MD, US
Eastman Kodak Company
Rochester, NY, US
Regenlab Usa Llc
Jersey City, NJ, US
3d Global Biotech Inc.
New Taipei City, TW
510(k) clearances
367 clearances for this product code
- Inovar Biologicals, Inc.May 22, 1989
K892938 · AMNIO-GROW TM
- Clonetics Corp.Feb 24, 1989
K890701 · ENDOTHELIAL GROWTH MEDIUM (EGM)
- Clonetics Corp.Feb 24, 1989
K890700 · MELANOCYTE GROWTH MEDIUM (MGM)
- Cell Ent., Inc.Feb 10, 1989
K890482 · ABC, ABC-1X, ABC(TM)
- Hyclone Laboratories, Inc.Nov 30, 1988
K884654 · ALPHACALF SERUM
- Sigma Chemical Co.Nov 22, 1988
K884573 · HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891
- Sigma Chemical Co.Nov 22, 1988
K884572 · RPMI-1640 HYBRI-MAX, PROD. NO. R5382
- Sigma Chemical Co.Nov 22, 1988
K884574 · DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785