Company ยท US
Hydro-Med Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1994. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MMP | Cover, Barrier, Protective | 2 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 |
| IPM | Cover, Limb | 1 |
| IWQ | Curtain, Protective, Radiographic | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KME | Bedding, Disposable, Medical | 1 |
| KQM | Camera, Surgical And Accessories | 1 |
| LPZ | Container, Frozen Donor Tissue Storage | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 1994 | K944198 | SURGICAL MICROSCOPE DRAPE Hydro-Med Products, Inc. | MMP |
| Nov 14, 1994 | K940151 | ULTRASOUND PROBE DRAPE Hydro-Med Products, Inc. | IYO |
| Oct 28, 1994 | K940152 | CAMERA COVER WITH TEAR TIP Hydro-Med Products, Inc. | FEM |
| Oct 28, 1994 | K934630 | UNIVERSAL VIDEO/LASER ARM DRAPE Hydro-Med Products, Inc. | KKX |
| Oct 15, 1992 | K923099 | X-RAY DRAPES Hydro-Med Products, Inc. | IWQ |
| Feb 10, 1987 | K863872 | TAMPER HAMPER Hydro-Med Products, Inc. | LPZ |
| Aug 21, 1985 | K853281 | EASYTOP Hydro-Med Products, Inc. | |
| Aug 1, 1984 | K842304 | THE PATHFINDER Hydro-Med Products, Inc. | |
| Mar 19, 1984 | K834407 | STERILE DISPOSABLE SPINAL NEEDLES Hydro-Med Products, Inc. | FMI |
| Oct 20, 1981 | K812405 | STERILE TV CAMERA & CORD COVER Hydro-Med Products, Inc. | KQM |
| Apr 30, 1979 | K790659 | INFANT SCALE DISPOSABLE LINER Hydro-Med Products, Inc. | KME |
| Aug 14, 1978 | K780905 | LIMB COVER Hydro-Med Products, Inc. | IPM |
| Jun 21, 1978 | K780452 | THERA-PAK Hydro-Med Products, Inc. | ILO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2005 | Hydro Med Products, Inc 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 Terminated |
MMP | K940151 |