Company ยท US
Physician Engineered Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2012. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 3, 2012 | K110550 | BRIGHT EMBRACE MODEL SBL60 Physician Engineered Products, Inc. | LBI |
| Apr 23, 2010 | K093618 | BILI-MIRROR MODEL BLM-1 Physician Engineered Products, Inc. | LBI |
| May 20, 1998 | K974830 | ULTRA BILI LIGHT Physician Engineered Products, Inc. | LBI |
| Nov 21, 1988 | K883818 | MODIFIED REFLUX REDUCER Physician Engineered Products, Inc. | FMS |
| Jun 20, 1988 | K882291 | RETROFIT BABY FACE SHIELD (RFS) Physician Engineered Products, Inc. | LBI |
| Jun 16, 1988 | K882278 | RESUSCITATION BAG CONTROLLER (RBC) Physician Engineered Products, Inc. | BTM |
| Dec 11, 1987 | K873700 | INSTITUTIONAL BILI LIGHT (IBL) Physician Engineered Products, Inc. | LBI |
| Jun 17, 1985 | K850599 | HOME BILI LIGHTS-MODEL 100 Physician Engineered Products, Inc. | LBI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2015 | Physician Engineered Products, Inc. Bright Embrace, a Single Bili Light for newborn phototherapy
Distributed by: Physician Engineered Products, Inc., Model SBL60 Terminated |
LBI | K110550 |