# Maxxim Medical

- Location (FDA's records): Clearwater, FL
- FDA decisions: 28 (1994–2002): 28 510(k) clearances
- Names in FDA's records: Maxxim Medical (26); Maxxim Medical, Inc. (2)
- Product codes: KGO (10), LZA (4), GEI (2), LYZ (2), KCT (1), FOZ (1), DTL (1), DQX (1), MGQ (1), GXY (1), EGJ (1), DQO (1)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 14 (2 its own)
- Recalls linked to its devices: 52 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 4 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Argon Medical Corp.: 2 (https://510kreport.com/company/argon-medical)
- Ansell Edmont Industrial, Inc.: 1 (https://510kreport.com/company/ansell-edmont-industrial)
- Scientific Device Manufacturer, LLC: 1 (https://510kreport.com/company/scientific-device-manufacturer)
- Advance Medical Designs, Inc.: 1 (https://510kreport.com/company/advance-medical-designs)
- Kendall Healthcare Products Co. Div.Of Tyco Health: 1 (https://510kreport.com/company/kendall-healthcare-products-co-div-of-tyco-health)

## Firms that cite its devices most
- Wilshire Technologies: 3 (https://510kreport.com/company/wilshire-technologies)
- Coombs Medical Device Consulting: 1 (https://510kreport.com/company/coombs-medical-device-consulting)
- Coeur, Inc.: 1 (https://510kreport.com/company/coeur)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)
- Yty Industry (Manjung) Sdn Bhd: 1 (https://510kreport.com/company/yty-industry-manjung-sdn-bhd)
- Medigloves, Ltd.: 1 (https://510kreport.com/company/medigloves)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Its most-cited devices
- K963749: High Pressure Injection Lines (1996), cited by 4
- K011198: Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental (2001), cited by 3
- K002933: Sterile Sensicare Synthetic Polyisoprene Powder-Free Surgical Gloves (2000), cited by 2
- K963388: Vessel Dilator (1997), cited by 2
- K991615: Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove (1999), cited by 1
- K984189: Argon Multi-Lumen Central Venous Catheter (1999), cited by 1

## Recent decisions
- K023236: Sensicare -C Synthetic Polyisoprene Powder-Free Surgical Gloves (Nov 12, 2002)
- K021452: Sterile Sensicare Advantix Powder Free Polyurethane Medical/Dental Examination Glove (Aug 1, 2002)
- K011905: Sniper Elite Model-or-E3872XX Series (Aug 28, 2001)
- K002847: Introducer with Distal Radiopaque Marker Band, Model or-4926XX (May 31, 2001)
- K011198: Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental (May 17, 2001)
- K010297: Sensicare Synthetic Powder Free Surgical Gloves (Poly Isoprene) (Feb 16, 2001)
- K002933: Sterile Sensicare Synthetic Polyisoprene Powder-Free Surgical Gloves (Oct 19, 2000)
- K001343: Eudermic PF Powder-Free Surgical Gloves (Jun 12, 2000)

Source page: https://510kreport.com/company/maxxim-medical