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Company · US

River Medical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2003. Name variants (Inc, Corp, punctuation) are merged.

16510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
ETB	Prosthesis, Partial Ossicular Replacement	4
FRN	Pump, Infusion	4
ETD	Tube, Tympanostomy	3
EQH	Source, Carrier, Fiberoptic Light	1
ETA	Replacement, Ossicular Prosthesis, Total	1
FMF	Syringe, Piston	1
FPA	Set, Administration, Intravascular	1
LDF	Electrode, Pacemaker, Temporary	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jun 11, 2003	K023174	DISPOSABLE TEMPORARY PACING WIRE River Medical, Inc.	LDF
Nov 15, 1995	K944352	SMARTDOSE III INFUSION CONTAINER River Medical, Inc.	FRN
Nov 15, 1995	K944351	SMARTDOSE IV PREFILLED INFUSION CONTAINER River Medical, Inc.	FRN
Jun 14, 1995	K945298	SMARTFLOW I ADMINISTRATION SET River Medical, Inc.	FPA
Apr 28, 1995	K943692	SMART DOSE(TM) River Medical, Inc.	FRN
Mar 31, 1994	K932895	RIVER PUMP River Medical, Inc.	FRN
Mar 1, 1994	K933335	RIVER VIAL ADAPTER River Medical, Inc.	FMF
Dec 27, 1991	K915120	TEF/PLATINUM PISTON River Medical, Inc.	ETB
Dec 23, 1991	K915121	TEF/WIRE PISTON River Medical, Inc.	ETB
Dec 18, 1991	K913287	H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET River Medical, Inc.	ETB
Dec 18, 1991	K913286	H/A TOTAL-REGULAR, H/A TOTAL-OFFSET River Medical, Inc.	ETA
Dec 18, 1991	K913285	PTFE PISTON River Medical, Inc.	ETB
May 30, 1991	K905437	RIVER MEDICAL MICRODRILL SYSTEM River Medical, Inc.	EQH
Jan 28, 1991	K904597	GROMMET STYLE VENTURI River Medical, Inc.	ETD
Jan 28, 1991	K904594	COLLAR BUTTON STYLE VENTURI River Medical, Inc.	ETD
Jan 28, 1991	K904592	BOBBIN STYLE VENTURI River Medical, Inc.	ETD

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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