Parexel Intl. Corp.
Mchenry, IL, US
Parexel Intl. Corp. appears in FDA device records in Mchenry, IL. 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 Parexel Intl. Corp. between 1984 and 1991. The busiest year on record is 1984, with 3. The most recent is 1991, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 2 |
| 1989 | 1 |
| 1991 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K900385 | ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE | DSI | Substantially Equivalent | |
| K904902 | SMA 26 TRANSDUCER | ITX | Substantially Equivalent | |
| K904901 | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC | ITX | Substantially Equivalent | |
| K884800 | ACTA GENOS ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K862414 | FUJI CR IMAGING PLATE | EAM | Substantially Equivalent | |
| K864519 | PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) | LLZ | Substantially Equivalent | |
| K862416 | FTI 100 MEDICAL THERMAL IMAGER | LMC | Substantially Equivalent | |
| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | IWZ | Substantially Equivalent | |
| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | GCY | Substantially Equivalent | |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | BYY | Substantially Equivalent | |
| K851322 | PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K842123 | PERSONAL CL SINGLE-CHANNEL ELECTROCAR | DSI | Substantially Equivalent | |
| K842208 | NATURA-TONE OR LUXOPAL CL ACRYLIC | ELM | Substantially Equivalent | |
| K841826 | NATURA-DENT VACUUM-FIRED PORCELAIN TEETH | ELL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- LMCCamera, Multi Format, Radiological
- ELMDenture, Plastic, Teeth
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- IWZFilm, Radiographic
- EAMScreen, Intensifying, Radiographic
- LLZSystem, Image Processing, Radiological
- ELLTeeth, Porcelain
- ITXTransducer, Ultrasonic, Diagnostic
- BYYTube, Aspirating, Flexible, Connecting
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