Medical Device Manufacturer · US , Walker , MI

Biodynamics Corp.

21 submissions · 21 cleared · Since 1980
21
Total
21
Cleared
0
Denied

Biodynamics Corp. — FDA 510(k) Submissions

Biodynamics Corp. has submitted 21 FDA 510(k) premarket notifications since 1980, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plethysmograph, Impedance, Colorimeter, Photometer, Spectrophotometer For Clinical Use, Glucose Oxidase, Glucose, Centrifuges (micro, Ultra, Refrigerated) For Clinical Use, Apparatus, Autotransfusion . Use the specialty filter in the sidebar to narrow results.

21 devices
1–12 of 21
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
K051675 · MNW Analyzer, Body Composition · Gastroenterology & Urology
Mar 2006 266d
BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
K884033 · DSB Plethysmograph, Impedance · Cardiovascular
Nov 1988 55d
BIODYNAMICS AUTOTRANSFUSION RESERVOIR
K881631 · CAC Apparatus, Autotransfusion · Anesthesiology
Sep 1988 148d
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
K881968 · DSB Plethysmograph, Impedance · Cardiovascular
Jul 1988 78d
BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER
K874361 · DSB Plethysmograph, Impedance · Cardiovascular
Mar 1988 145d
AUTOTRANSFUSION APPARATUS
K873807 · CAC Apparatus, Autotransfusion · Anesthesiology
Mar 1988 173d
ADR-22 AUTOMATIC DIALYZER REPROCESSOR
K874034 · LIF Dialyzer Reprocessing System · Gastroenterology & Urology
Oct 1987 18d
INFUMIX MIXING CONTAINER
K870052 · KPE Container, I.v. · General Hospital
Feb 1987 51d
PLATELET CENTRIFUGE
K822715 · JQC Centrifuges (micro,... · Hematology
Sep 1982 23d
UNIVERSAL CENTRIFUGE
K822716 · JPI Device, Hematocrit Measuring · Hematology
Sep 1982 23d
BASIC CENTRIFUGE
K822422 · JQC Centrifuges (micro,... · Hematology
Sep 1982 21d
URICACID
K821741 · KNK Acid, Uric, Uricase... · Chemistry
Jul 1982 18d
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