Keymed, Inc.
San Diego, CA, US
Keymed, Inc. appears in FDA device records in San Diego, CA. FDA records list 29 510(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
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Keymed, Inc. between 1981 and 2010. The busiest year on record is 1981, with 5. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 5 |
| 1982 | 5 |
| 1983 | 3 |
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 5 |
| 1987 | 1 |
| 1988 | 1 |
| 1993 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | FEQ | Substantially Equivalent | |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | FEB | Substantially Equivalent | |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | FCX | Substantially Equivalent | |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | NVE | Substantially Equivalent | |
| K864801 | THE KEYMED HI-LIGHT 250 LIGHT SOURCE | GCT | Substantially Equivalent | |
| K862000 | KEYMED FLEXIBLE ESOPHAGEAL DILATORS | KNQ | Substantially Equivalent | |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | KCT | Substantially Equivalent | |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | FLG | Substantially Equivalent | |
| K860704 | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | NZA | Substantially Equivalent | |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | JAF | Substantially Equivalent | |
| K854304 | KEYMED OFFICE COUCH | FPO | Substantially Equivalent | |
| K853421 | THE KEYMED VARI-HEIGHT PATIENT COUCH | FPO | Substantially Equivalent | |
| K841822 | KEYMED SIGMOIDOSCOPE SUCTION UNIT | DRM | Substantially Equivalent | |
| K841331 | OLYMPUS KC-10 MOBILE DISINFEC-STAT | NZA | Substantially Equivalent | |
| K841399 | BRONCHOSCOPE SUCTION UNIT | BTA | Substantially Equivalent | |
| K840920 | KEYMED MOBILE ENDOSCOPY PATIENT COUCH | FPO | Substantially Equivalent | |
| K830586 | TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR | KNQ | Substantially Equivalent | |
| K830247 | SPLIT COLON STIFFENING TUBE | FED | Substantially Equivalent | |
| K830026 | FIBERSCOPE DISINFECTANT IRRIGATOR | FEB | Substantially Equivalent | |
| K822401 | ST. MARK'S RECTAL BIOPSY FORCEPS | KOA | Substantially Equivalent | |
| K820739 | KEYMED KEY VAC SUCTION PUMP | BTA | Substantially Equivalent | |
| K820652 | EXHALED HYDROGEN MONITOR | Substantially Equivalent | ||
| K813325 | KEY MED FOREIGN BODY REMOVAL TUBE | FED | Substantially Equivalent | |
| K820152 | KEY MED LEEDS ENDOSCOPE DISINFECTOR | FEB | Substantially Equivalent | |
| K813133 | KEYMED KEY LIGHT | HET | Substantially Equivalent | |
| K810818 | KEY-MED FIBRESCOPE DISINFECTION TROLLEY | FEB | Substantially Equivalent | |
| K810392 | OESOPHAGEAL THERAPY KIT | KNT | Substantially Equivalent | |
| K810393 | ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST. | FET | Substantially Equivalent | |
| K810180 | WILLIAMS OESOPHAGEAL VARICES INJECT TUBE | FED | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- NZAAccessories, Germicide, Cleaning, For Endoscopes
- FLGCleaner, Ultrasonic, Medical Instrument
- DRMCompressor, Cardiac, External
- KNQDilator, Esophageal
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- HETLaparoscope, Gynecologic (And Accessories)
- GCTLight Source, Endoscope, Xenon Arc
- JAFMonitor, Ultrasonic, Nonfetal
- FEQPump, Air, Non-Manual, For Endoscope
- BTAPump, Portable, Aspiration (Manual Or Powered)
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- FPOStretcher, Wheeled
- KOASurgical Instruments, G-U, Manual (And Accessories)
- KNTTubes, Gastrointestinal (And Accessories)
- NVEWasher, Cleaner, Automated, Endoscope
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