Company · US

Andover Medical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1991. Name variants (Inc, Corp, punctuation) are merged.

21510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
DRX	Electrode, Electrocardiograph	8
GXY	Electrode, Cutaneous	3
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	2
DYG	Catheter, Flow Directed	2
KRB	Probe, Thermodilution	2
CAT	Cannula, Nasal, Oxygen	1
DPS	Electrocardiograph	1
DSH	Recorder, Magnetic Tape, Medical	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Feb 7, 1991	K905729	CANMED 451 Andover Medical, Inc.	DRX
Aug 17, 1990	K903427	NORTECH MODEL 86901000 ELECTRODE Andover Medical, Inc.	GXY
Jan 12, 1989	K885171	MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE Andover Medical, Inc.	DRO
May 9, 1986	K860636	FASTRACE III, ECG ELECTRODE Andover Medical, Inc.	DPS
May 8, 1986	K854433	ECG MONITORING/DEFIBRILLATION ELECTRODE Andover Medical, Inc.	DRX
Apr 1, 1986	K860535	UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) Andover Medical, Inc.	CAT
Mar 31, 1986	K860283	AMI CARDIO-PAD Andover Medical, Inc.	DRO
Nov 20, 1984	K843412	FLOW DIRECTED THERMODILUTION CATH W/VEN Andover Medical, Inc.	KRB
Nov 20, 1984	K843410	FLOW-DIRECTED PEDIATRIC THERMODIL- CATH Andover Medical, Inc.	KRB
Oct 18, 1984	K843411	THERMAL DILUTION CATHETER Andover Medical, Inc.	DYG
Oct 18, 1984	K843409	FLOW-DIRECTED THERMODILUTION CATH Andover Medical, Inc.	DYG
Jun 30, 1983	K831785	NEURO EASE Andover Medical, Inc.	GXY
Dec 30, 1982	K823414	HOLTER KIT MODEL #5000 SERIES Andover Medical, Inc.	DSH
Oct 15, 1982	K822798	DISPOSABLE ELECTRODE #1900 Andover Medical, Inc.	DRX
Nov 2, 1981	K812878	THE NEW 1600 ELECTRODE Andover Medical, Inc.	DRX
Sep 25, 1981	K812276	DISPOSABLE ELECTRODE, #1610 Andover Medical, Inc.	DRX
Feb 19, 1981	K810271	DIRECT CURRENT BONE GROWTH STIM. AN. PAD Andover Medical, Inc.
Mar 27, 1979	K790316	ELECTRODE, ELECTROFLEX Andover Medical, Inc.	GXY
Jun 19, 1978	K780908	SELF-RETAINING ELECTRODE SER. #4000-100 Andover Medical, Inc.	DRX
Aug 23, 1976	K760358	ELECTRODE SERIES 1600 Andover Medical, Inc.	DRX
Aug 23, 1976	K760280	ELECTRODE SERIES 1401 Andover Medical, Inc.	DRX

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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