Dyonics, Inc.

Walker, MI, US

Dyonics, Inc. appears in FDA device records in Walker, MI. FDA records list 19 510(k) clearances between 1978-02-01 and 1990-02-16, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 19
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 19 510(k) clearances for Dyonics, Inc. between 1978 and 1990. The busiest year on record is 1988, with 4. The most recent is 1990, with 2.

Clearances by year, as a table

510(k) clearance decisions for Dyonics, Inc., by decision year
Year	Clearances
1978	1
1979	1
1981	1
1982	1
1983	1
1984	2
1986	1
1987	1
1988	4
1989	4
1990	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K900070	MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM	HRX	Substantially Equivalent	1990-02-16
K896416	DYONICS SHOULDER PORTAL SYSTEM	HRX	Substantially Equivalent	1990-01-02
K893136	SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY	HRX	Substantially Equivalent	1989-12-14
K890665	MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES	HRX	Substantially Equivalent	1989-11-03
K894728	DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE	HRX	Substantially Equivalent	1989-08-18
K892062	PS3500 ARTHROSCOPIC SURGICAL SYSTEM	HRX	Substantially Equivalent	1989-06-23
K884839	MODIFIED SAW BLADES TO THE SAGITAL SAW	KIJ	Substantially Equivalent	1988-12-07
K881876	DYNAMIC CRUCIATE TESTER	LYH	Substantially Equivalent	1988-11-17
K880739	DYONICS DRILL GUIDE/ISOMETER SYSTEM	LXI	Substantially Equivalent	1988-03-21
K880150	PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM	HWE	Substantially Equivalent	1988-03-04
K870212	ARTHROSCOPIC SHOULDER HOLDER	HST	Substantially Equivalent	1987-02-20
K862017	ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT	HRX	Substantially Equivalent	1986-12-15
K843121	GUIDE TO THE KNEE	BWN	Substantially Equivalent	1984-09-07
K833943	MENISCAL SUTURING SYSTEM	LXH	Substantially Equivalent	1984-02-27
K833587	DISPOSABLE ARTHROSCOPY BLADE	HRX	Substantially Equivalent	1983-11-14
K820367	INTRA-ARTICULAR SURGICAL SYSTEM	KIJ	Substantially Equivalent	1982-05-07
K812506	THE ARTHROFILE	HTR	Substantially Equivalent	1981-09-24
K790502	DYONICS STEROTOXIC POSITIONER	HAW	Substantially Equivalent	1979-04-05
K771218	INTRA-ARTICULAR SHAVER	KIJ	Substantially Equivalent	1978-02-01

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