Medical Device Manufacturer · US , Mchenry , IL

Impact Instrumentation, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1981

Recent clearances: IMPACT MODEL 323 ASPIRATOR, UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR, UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR

27

Total

27

Cleared

0

Denied

FDA 510(k) Regulatory Record - Impact Instrumentation, Inc. General & Plastic Surgery ✕

8 devices

1-8 of 8

Cleared Mar 10, 2014

IMPACT MODEL 323 ASPIRATOR

General & Plastic Surgery · 144d

Cleared Apr 18, 1995

ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT

General & Plastic Surgery · 22d

Cleared Jan 05, 1995

ELECTRIC VACUM PUMP

General & Plastic Surgery · 304d

Cleared Aug 03, 1984

IMPACT MODEL 316

General & Plastic Surgery · 73d

Cleared Jun 11, 1984

IMPACT MODEL 308

General & Plastic Surgery · 56d

Cleared Mar 02, 1982

IMPACT, MODELS 306/307

General & Plastic Surgery · 22d

Cleared Feb 23, 1982

IMPACT, MODEL E-12

General & Plastic Surgery · 15d

Cleared Feb 23, 1982

IMPACT, MODEL 302

General & Plastic Surgery · 15d