Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2021-09-02 | NAI | No action indicated | Applied Medical Resources Corp | 0 |
| 2021-09-02 | NAI | No action indicated | Applied Medical Resources Corp | 0 |
| 2018-11-20 | NAI | No action indicated | Applied Medical Resources Corp | 0 |
| 2018-11-20 | NAI | No action indicated | Applied Medical Resources Corp | 0 |
| 2017-03-31 | VAI | Voluntary action indicated | Applied Medical Resources Corp | 0 |
| 2017-03-31 | VAI | Voluntary action indicated | Applied Medical Resources Corp | 0 |
| 2015-12-03 | NAI | No action indicated | Applied Medical Resources Corporation | 0 |
| 2015-10-14 | OAI | Official action indicated | Applied Medical Resources Corp | 8 |
| 2015-10-14 | OAI | Official action indicated | Applied Medical Resources Corp | 8 |
| 2015-04-10 | WL | Warning Letter | Applied Medical Resources Corp | — |
| 2015-04-10 | WL | Warning Letter | Applied Medical Resources Corp | — |
| 2014-12-16 | OAI | Official action indicated | Applied Medical Resources Corp | 8 |
| 2014-12-16 | NAI | No action indicated | Applied Medical Distribution Center | 0 |
| 2014-12-16 | OAI | Official action indicated | Applied Medical Resources Corp | 8 |
Similar devices
- FloNavi Endoscopic Camera Head Guangdong Optomedic Technologies, Inc.
- FloNavi Endoscopic Camera Head Guangdong Optomedic Technologies, Inc.
- Image Processing Unit Guangdong Optomedic Technologies, Inc.
- Image Processing Unit Guangdong Optomedic Technologies, Inc.
- 04262494462733 Doppkon GmbH & Co. KG
- Open Field Fluorescence Imaging Head Guangdong Optomedic Technologies, Inc.
- Open Field Fluorescence Imaging Head Guangdong Optomedic Technologies, Inc.
- SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO OBP CORPORATION
- VEQTRON Guangdong Optomedic Technologies, Inc.
- VEQTRON Guangdong Optomedic Technologies, Inc.
- VEQTRON Guangdong Optomedic Technologies, Inc.
- """2.0/2.4MM"" FRACTURE SYSTEM" BIOMET MICROFIXATION, INC
Select up to two to place side-by-side with this device.