Maxxim Medical
Hone Path, SC, US
Maxxim Medical appears in FDA device records in Hone Path, SC. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Maxxim Medical between 1994 and 2002. The busiest year on record is 1997, with 7. The most recent is 2002, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 3 |
| 1997 | 7 |
| 1999 | 6 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023236 | SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K021452 | STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES | DQX | Substantially Equivalent | |
| K002847 | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX | DYB | Substantially Equivalent | |
| K011198 | SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL | LZA | Substantially Equivalent | |
| K010297 | SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) | LZA | Substantially Equivalent | |
| K002933 | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K001343 | EUDERMIC PF POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K992865 | SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE | LYZ | Substantially Equivalent | |
| K991615 | POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K992122 | TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE | LYZ | Substantially Equivalent | |
| K984189 | ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | |
| K983982 | SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K972071 | BOVIE MODEL X40 | GEI | Substantially Equivalent | |
| K972161 | BOVIE MODEL X15 | GEI | Substantially Equivalent | |
| K964440 | EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS) | KGO | Substantially Equivalent | |
| K963388 | VESSEL DILATOR | DRE | Substantially Equivalent | |
| K964980 | ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM | KGO | Substantially Equivalent | |
| K964962 | SENTURA SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K962813 | DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K963749 | HIGH PRESSURE INJECTION LINES | DTL | Substantially Equivalent | |
| K962513 | DERMAPLEX HYDROGEL WOUND DRESSING | MGQ | Substantially Equivalent for Some Indications | |
| K954325 | NEOLON NEOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K935868 | DYNAPHOR(TM) TWO | EGJ | Substantially Equivalent | |
| K941986 | CUTANEOUS ELECTRODE | GXY | Substantially Equivalent | |
| K943674 | NEUTRALON LP BROWN LATEX SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K933560 | BARRIER PLASTIC PACKAGING (MODIFICATION) | KCT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- EGJDevice, Iontophoresis, Other Uses
- DREDilator, Vessel, For Percutaneous Catheterization
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- GXYElectrode, Cutaneous
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DYBIntroducer, Catheter
- LZAPolymer Patient Examination Glove
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- KGOSurgeon'S Gloves
- LYZVinyl Patient Examination Glove
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain