Infimed, Inc.
Liverpool, NY, US
Infimed, Inc. appears in FDA device records in Liverpool, NY. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Infimed, Inc. between 1993 and 2011. The busiest year on record is 1996, with 3. The most recent is 2011, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1996 | 3 |
| 1997 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2002 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112180 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) | OWB | Substantially Equivalent | |
| K111344 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) | OWB | Substantially Equivalent | |
| K103416 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM | OWB | Substantially Equivalent | |
| K101833 | INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | OWB | Substantially Equivalent | |
| K093066 | I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | OWB | Substantially Equivalent | |
| K012490 | ORION DIGITAL IMAGING SYSTEM | OWB | Substantially Equivalent | |
| K992392 | RTLX | MUH | Substantially Equivalent | |
| K992794 | STINGRAY DR, MODEL 1 | MQB | Substantially Equivalent | |
| K992575 | CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 | LLZ | Substantially Equivalent | |
| K962422 | INFIMED DENTAL SYSTEM | EHD | Substantially Equivalent | |
| K963037 | PATRIOT | LLZ | Substantially Equivalent | |
| K961689 | INFINET | LMD | Substantially Equivalent | |
| K960510 | THERAVIEW | IYE | Substantially Equivalent | |
| K933299 | QL MULTIPULSE 2048 | JAA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- IYEAccelerator, Linear, Medical
- OWBInterventional Fluoroscopic X-Ray System
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- MUHSystem, X-Ray, Extraoral Source, Digital
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- EHDUnit, X-Ray, Extraoral With Timer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain