Panels › General Hospital › Product code FRP · Class 1
Holder, Infant Position
Regulation 880.5680
0510(k)s in 12 months (14 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FRP
| Company | 510(k)s | Recalls |
|---|---|---|
| Pedicraft, Inc. | 2 | 0 |
| Alfred E Mann Inst. For Biomedical Engineering | 1 | 0 |
| Cr Enterprises, LLC | 1 | 0 |
| K.Bowmed, Inc. | 1 | 0 |
| Kamber Corporation | 1 | 0 |
| Kaye Products, Inc. | 1 | 0 |
| Life Innovations, LLC | 1 | 0 |
| The Ludlow Company LP | 1 | 0 |
| Ohio Medical Instrument Co., Inc. | 1 | 0 |
| Plastic Surgery Solutions, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2009 | K082367 | INFANT SLEEP BEANIE Life Innovations, LLC | FRP |
| Jun 5, 2009 | K090284 | RES-Q INFANT WEDGE AND SLING Cr Enterprises, LLC | FRP |
| Oct 24, 2006 | K062143 | KOZY COMFORT INFANT POSITIONER Alfred E Mann Inst. For Biomedical Engineering | FRP |
| Jul 11, 2006 | K060986 | HEAD BED Steven H. Warnock, M.D. | FRP |
| Dec 8, 2005 | K051300 | ROBIN HOOD VEST Kamber Corporation | FRP |
| Aug 3, 2004 | K041996 | NIGHTFORM Plastic Surgery Solutions, LLC | FRP |
| Jan 24, 2001 | K003511 | KENDALL-LTP TURNER SAVE-A-LINE The Ludlow Company LP | FRP |
| Jan 19, 1995 | K943017 | NEONATAL RESTRAINT AND COMFORT SYSTEMS K.Bowmed, Inc. | FRP |
| Jan 26, 1994 | K932636 | THE TUCKER SLING Tucker Designs, Ltd. | FRP |
| Mar 13, 1991 | K905630 | INFANT REFLUX SLING Pedicraft, Inc. | FRP |
| Mar 13, 1991 | K905629 | PEDICRAFT INFANT REFLUX WEDGE Pedicraft, Inc. | FRP |
| Jan 31, 1989 | K882544 | CUDDLE UP PILLOW Ohio Medical Instrument Co., Inc. | FRP |
| Jan 23, 1985 | K844176 | PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS Premie Comfort Products | FRP |
| Mar 20, 1981 | K810609 | PEDIATRIC POSITION HOLDER Kaye Products, Inc. | FRP |
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