Electromedics, Inc.

Moonachie, NJ, US

Electromedics, Inc. appears in FDA device records in Moonachie, NJ. FDA records list 42 510(k) clearances between 1977-11-02 and 2008-07-23, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 42
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 42 510(k) clearances for Electromedics, Inc. between 1977 and 2008. The busiest year on record is 1983, with 7. The most recent is 2008, with 1.

Clearances by year, as a table

510(k) clearance decisions for Electromedics, Inc., by decision year
Year	Clearances
1977	6
1981	4
1982	5
1983	7
1984	1
1985	2
1986	1
1987	2
1990	4
1991	2
1992	1
1993	4
1994	2
2008	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K073616	FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE	GEI	Substantially Equivalent	2008-07-23
K934964	ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR	FLL	Substantially Equivalent	1994-03-07
K933832	ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR	FLL	Substantially Equivalent	1994-01-28
K934355	ELECTROMEDICS BLOOD HEAT EXCHANGER	DTR	Substantially Equivalent	1993-12-03
K930154	EL2-SERIES BLOOD COLLECTION REERVOIR	DTN	Substantially Equivalent	1993-07-01
K926250	ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR	DTN	Substantially Equivalent	1993-02-19
K925412	ELECTROMEDICS TISSUE TRAP/ #TT280	BYZ	Substantially Equivalent	1993-02-05
K915737	AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR	DTN	Substantially Equivalent	1992-09-03
K910238	PORTABLE AUTO TRANSFUSION SYSTEM 500	CAC	Substantially Equivalent	1991-06-19
K910935	MODIFIED PYROGEN TESTING	DTM	Substantially Equivalent	1991-05-16
K902723	ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20	DTM	Substantially Equivalent	1990-12-13
K903392	ELECTROMEDICS BT422-120 AND BT422-40	CAC	Substantially Equivalent	1990-09-06
K893218	AP900/PRP MODULE AND ACCESSORIES, MODIFICATION	CAC	Substantially Equivalent	1990-06-12
K900104	TCPM II TOURNIQUET CUFF PRESSURE MONITOR	KCY	Substantially Equivalent	1990-03-15
K873561	ELECTROMEDICS D1079E	DTR	Substantially Equivalent	1987-11-05
K871847	BT-795/ATS	CAC	Substantially Equivalent	1987-06-19
K860306	BT-795/P AUTOMATED AUTOTRANS	CAC	Substantially Equivalent	1986-03-06
K842391	ACR 2500 CARDIOTOMY RESERVOIR FILTER	DTN	Substantially Equivalent	1985-05-21
K844803	POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE	DTP	Substantially Equivalent	1985-04-29
K832897	MODEL TTPM TIME TEMP. PRESSURE MONITOR	DRS	Substantially Equivalent	1984-03-22
K832272	TOURNIQUET CUFF PRESSURE MONITOR #TCPM	LDQ	Substantially Equivalent	1983-11-28
K831458	CARDIOPLEGIA RECIRCULATION SYS-BL 705/A	DWB	Substantially Equivalent	1983-10-20
K831743	STERILE FOLEY CATHETERS & UROLOGICAL	KOD	Substantially Equivalent	1983-09-12
K830639	HI FLEX D-700 MODULAR BUBBLE OXYGENA-	DTZ	Substantially Equivalent	1983-05-25
K830592	DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE	FLL	Substantially Equivalent	1983-05-18
K830735	BT 795/A AUTOTRANS	CAC	Substantially Equivalent	1983-05-02
K823681	MODEL ICPM & ACCESSORIES	JFC	Substantially Equivalent	1983-02-23
K823126	MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER	BZW	Substantially Equivalent	1982-11-16
K822098	BT 794-BLOOD/FLUID WARMER	LGZ	Substantially Equivalent	1982-08-20
K822097	D645-BACTERIOLOGICAL GAS LINE FILTER	KRI	Substantially Equivalent	1982-07-30
K813264	D6ZO DISPOSABLE HEAT EXCHANGER	DTR	Substantially Equivalent	1982-07-06
K813459	REUSABLE & DISPOSABLE TEMP. PROBES	FLL	Substantially Equivalent	1982-03-26
K812455	SUCKER CARDIOTOMY RETURN, C.P. BYPASS	DTN	Substantially Equivalent	1981-10-23
K812292	AUTOTRANS BT795	CAC	Substantially Equivalent	1981-10-23
K812758	PHYSIOLOGICAL PRESSURE TRANSDUCER	DRS	Substantially Equivalent	1981-10-20
K803277	TYGON TUBING	DWE	Substantially Equivalent	1981-01-13
K771996	TELETHERMOMETER MODEL T T-100	FLL	Substantially Equivalent	1977-11-22
K771995	ELECTROTHERM MODELS TC-100 & M-99	FLL	Substantially Equivalent	1977-11-22
K771999	ELECTROTHERM MODELS F&C18,14,78, F84	FLL	Substantially Equivalent	1977-11-15
K771998	TEMP-A-LERT MODEL TA-986	FLL	Substantially Equivalent	1977-11-15
K771997	TELETHERMOMETER MODEL T T-400	FLL	Substantially Equivalent	1977-11-15
K771994	ELECTROTHERM MODEL HT-1	FLL	Substantially Equivalent	1977-11-02

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain