Physician Engineered Products, Inc.
FDA Regulatory Profile
Physician Engineered Products, Inc. appears in FDA public data with 1 recall, 8 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2486-2015, Class II) was initiated on Aug 31, 2013. Its most recent 510(k) clearance was granted on Feb 3, 2012.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2486-2015 | Class II | Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineere | Aug 31, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K110550 | BRIGHT EMBRACE MODEL SBL60 | Feb 3, 2012 |
| K093618 | BILI-MIRROR MODEL BLM-1 | Apr 23, 2010 |
| K974830 | ULTRA BILI LIGHT | May 20, 1998 |
| K883818 | MODIFIED REFLUX REDUCER | Nov 21, 1988 |
| K882291 | RETROFIT BABY FACE SHIELD (RFS) | Jun 20, 1988 |
| K882278 | RESUSCITATION BAG CONTROLLER (RBC) | Jun 16, 1988 |
| K873700 | INSTITUTIONAL BILI LIGHT (IBL) | Dec 11, 1987 |
| K850599 | HOME BILI LIGHTS-MODEL 100 | Jun 17, 1985 |