Hydro-Med Products, Inc.
Walker, MI, US
Hydro-Med Products, Inc. appears in FDA device records in Walker, MI. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Hydro-Med Products, Inc. between 1978 and 1994. The busiest year on record is 1994, with 4. The most recent is 1994, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 1 |
| 1981 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1987 | 1 |
| 1992 | 1 |
| 1994 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K944198 | SURGICAL MICROSCOPE DRAPE | MMP | Substantially Equivalent | |
| K940151 | ULTRASOUND PROBE DRAPE | IYO | Substantially Equivalent | |
| K940152 | CAMERA COVER WITH TEAR TIP | FEM | Substantially Equivalent | |
| K934630 | UNIVERSAL VIDEO/LASER ARM DRAPE | KKX | Substantially Equivalent | |
| K923099 | X-RAY DRAPES | IWQ | Substantially Equivalent | |
| K863872 | TAMPER HAMPER | LPZ | Substantially Equivalent | |
| K853281 | EASYTOP | Substantially Equivalent | ||
| K842304 | THE PATHFINDER | Substantially Equivalent | ||
| K834407 | STERILE DISPOSABLE SPINAL NEEDLES | FMI | Substantially Equivalent | |
| K812405 | STERILE TV CAMERA & CORD COVER | KQM | Substantially Equivalent | |
| K790659 | INFANT SCALE DISPOSABLE LINER | KME | Substantially Equivalent | |
| K780905 | LIMB COVER | IPM | Substantially Equivalent | |
| K780452 | THERA-PAK | ILO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- KMEBedding, Disposable, Medical
- KQMCamera, Surgical And Accessories
- LPZContainer, Frozen Donor Tissue Storage
- MMPCover, Barrier, Protective
- IPMCover, Limb
- IWQCurtain, Protective, Radiographic
- KKXDrape, Surgical, Antimicrobial
- FMINeedle, Hypodermic, Single Lumen
- ILOPack, Hot Or Cold, Water Circulating
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0384-05 | Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med Products Inc., 2930 Ladybird Ln., Dallas, TX 75220 | Defective packaging, potential for breech in sterility. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain