Medical Devices Inc.
Romulus, MI, US
Medical Devices Inc. appears in FDA device records in Romulus, MI. FDA records list 49 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 49 510(k) clearances for Medical Devices Inc. between 1977 and 2001. The busiest year on record is 1986, with 8. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 3 |
| 1979 | 2 |
| 1981 | 2 |
| 1982 | 2 |
| 1983 | 1 |
| 1985 | 1 |
| 1986 | 8 |
| 1987 | 3 |
| 1988 | 5 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 4 |
| 1992 | 4 |
| 1993 | 2 |
| 1994 | 4 |
| 1995 | 1 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 | MKJ | Substantially Equivalent | |
| K930084 | MICRO-ARTHROSCOPE | HRX | Substantially Equivalent for Some Indications | |
| K943126 | ELECTROFLEX | GXY | Substantially Equivalent | |
| K940012 | SMARTBRACE ELECTRODE | GXY | Substantially Equivalent | |
| K935132 | HOME MICROCURRENT HMC | GZJ | Substantially Equivalent | |
| K934619 | FLEXMATE | GZJ | Substantially Equivalent | |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | GCT | Substantially Equivalent | |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | FWF | Substantially Equivalent | |
| K923914 | IF-II (TM), MODEL 7200 | IPF | Substantially Equivalent | |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | GEI | Substantially Equivalent | |
| K915694 | MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR | HIF | Substantially Equivalent | |
| K915408 | BIPOLAR ENDOSTASIS PROBE, BEST (TM) | KNS | Substantially Equivalent | |
| K912182 | MEDITRON COMBINATION GENERATOR CG-2000 | GEI | Substantially Equivalent | |
| K912348 | SX90 (TM),MODEL 4800S | GZJ | Substantially Equivalent | |
| K905133 | STYLET TRACHAEL TUBE | BSR | Substantially Equivalent | |
| K903161 | MC II (TM), MODEL 7200S | GZJ | Substantially Equivalent | |
| K901302 | BIPOLARD POLYPECTOMY SYSTEM (TM) | GEI | Substantially Equivalent | |
| K895473 | DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S | GZJ | Substantially Equivalent | |
| K883462 | IF-II (TM), MODEL 9800 | LIH | Substantially Equivalent | |
| K890705 | MEDIMOD(TM), MODEL 8900 | GZJ | Substantially Equivalent | |
| K882888 | MULTIDAY, MODELS 8300 AND 8310 | GXY | Substantially Equivalent | |
| K882887 | PROGEL(TM), MODELS 8630 AND 8635 | GXY | Substantially Equivalent | |
| K882886 | PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 | GXY | Substantially Equivalent | |
| K882820 | MEDIPAC II EC (TM), MODEL 7900 | GZJ | Substantially Equivalent | |
| K881082 | GV 11 (TM), MODEL 9700 | IPF | Substantially Equivalent | |
| K872753 | MYOSTIM(TM), MODEL 6600 | IPF | Substantially Equivalent | |
| K872657 | ULTRAPAC II SX PLUS (TM) | GZJ | Substantially Equivalent | |
| K864968 | BACPAC (TM), MODEL 6500 | GZJ | Substantially Equivalent | |
| K864625 | MYOPAC (TM), MODEL 9600 | IPF | Substantially Equivalent for Some Indications | |
| K862337 | ULTRAPAC II SD (TM) | GZJ | Substantially Equivalent | |
| K862028 | ULTRAHESIVE II POSTOP ELECTRODE | GXY | Substantially Equivalent | |
| K861012 | SILENT PARTNER MODEL 10-1001 | CAW | Substantially Equivalent | |
| K861011 | SILENT PARTNER MODEL 10-2001 | CAW | Substantially Equivalent | |
| K854316 | FASTENS(TM) | GZJ | Substantially Equivalent | |
| K854761 | MINIPAC PERSONAL TOUCH (TM) | GZJ | Substantially Equivalent | |
| K854317 | MINIPAC (TM) | GZJ | Substantially Equivalent | |
| K851175 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE | GXY | Substantially Equivalent | |
| K831413 | SPEC IISX | GZJ | Substantially Equivalent | |
| K821979 | STERILE FOLEY CATHETERIZATION KITS | KNX | Substantially Equivalent | |
| K821978 | STERILE URETHRAL CATHETERIZATION SET | KNX | Substantially Equivalent | |
| K810593 | NEUROPAC ULTRA I | GZJ | Substantially Equivalent | |
| K803259 | CLOSED SYSTEM URETHRAL CATHETERIZ. SET | KOD | Substantially Equivalent | |
| K792312 | HEART RATE MONITOR MD-1 | DRT | Substantially Equivalent | |
| K792082 | GAVAGE FEEDING SET | EYN | Substantially Equivalent | |
| K781829 | NEUROPAC ULTRA II | GZJ | Substantially Equivalent | |
| K780831 | URINARY CATHETERIZATION SYSTEM W/O FOLEY | KNX | Substantially Equivalent | |
| K780134 | URINARY DRAINAGE MONITORING SYSTEM | FCN | Substantially Equivalent | |
| K771779 | CATHETERIZATION SYS. URINARY DRAINAGE | KOD | Substantially Equivalent | |
| K770320 | URINARY DRAINAGE SET, CLOSED, STERILE | KNX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3000210785 | 3000210785 | Medical Devices Inc. | 11501 Metro Airport Center Drive, Romulus, MI 48174 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- MKJAutomated External Defibrillators (Non-Wearable)
- FWFCamera, Television, Endoscopic, Without Audio
- KODCatheter, Urological
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- NADDressing, Wound, Occlusive
- GXYElectrode, Cutaneous
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- CAWGenerator, Oxygen, Portable
- HIFInsufflator, Laparoscopic
- LIHInterferential Current Therapy
- GCTLight Source, Endoscope, Xenon Arc
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- BSRStylet, Tracheal Tube
- EYNTray, Irrigation, Sterile
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
- FCNUrinary Drainage Collection Kit, For Indwelling 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