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Results of June 2008 Survey on 510(k) Submission Practices and FDA Clearances

Conducted by Compliance-Alliance
and Certified Compliance Solutions
 

Products Categories

Number of Responses

All responses

235

Anesthesiology devices

28

Cardiovascular devices

62

Clinical chemistry devices

20

Dental devices

19

Ear nose and throat devices

15

Gastroenterology-urology devices

25

General and plastic surgery devices

39

General hospital and personal use devices

51

Hematology and pathology devices

20

IVDs

62

Neurological devices

22

Obstetrical and gynecological devices

21

Ophthalmic devices

18

Orthopedic devices

31

Physical medicine devices

9

Radiological devices

45