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Company · US

Orange Medical Instruments, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1986. Name variants (Inc, Corp, punctuation) are merged.

12510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
CGA	Glucose Oxidase, Glucose	3
FMF	Syringe, Piston	3
CCE	Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling	2
FMI	Needle, Hypodermic, Single Lumen	1
FRN	Pump, Infusion	1
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	1
KMK	Device, Intravascular Catheter Securement	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Mar 13, 1986	K860808	CONTINUCATH Orange Medical Instruments, Inc., GB	CCE
Oct 3, 1985	K851822	BETA SCAN TRENDS METER Orange Medical Instruments, Inc.	CGA
Dec 18, 1984	K844796	MICRO-BETA U100 SYRINGE Orange Medical Instruments, Inc.	FMF
Nov 5, 1984	K843882	TRENDS LANCET Orange Medical Instruments, Inc.	KMK
Aug 23, 1984	K841369	BETA SCAN DRYSTIX Orange Medical Instruments, Inc.	CGA
May 9, 1984	K833705	BETAJECT BD U100 Orange Medical Instruments, Inc.	FMI
Apr 5, 1984	K833706	CLICK-COUNT U100 INSULIN SYRINGE Orange Medical Instruments, Inc.	FMF
Nov 14, 1983	K832691	BETA SCAN REAGENT STRIP Orange Medical Instruments, Inc.	CGA
Sep 26, 1983	K832793	NEOCATH 1000 W/HEPCOTE Orange Medical Instruments, Inc.	CCE
Aug 12, 1983	K831897	BETA I PROGRAMMABLE INFUSION PUMP Orange Medical Instruments, Inc.	FRN
Jul 19, 1983	K831523	BETA SCAN NORMAL CONTROL SOLUTION Orange Medical Instruments, Inc.	JJX
Oct 26, 1982	K822928	DISPOSABLE MICRO-INFUSION SYSTEM Orange Medical Instruments, Inc.	FMF

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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