Adept-Med Intl., Inc.

Diamond Springs, CA, US

ADEPT-MED INTL., INC. appears in FDA device records in Diamond Springs, CA. FDA records list 6 510(k) clearances between 1981-01-23 and 1994-03-25, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 6
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Adept-Med Intl., Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Adept-Med International Increcall

510(k) clearance history

FDA records hold 6 510(k) clearances for Adept-Med Intl., Inc. between 1981 and 1994. The busiest year on record is 1989, with 3. The most recent is 1994, with 1.

Clearances by year, as a table

510(k) clearance decisions for Adept-Med Intl., Inc., by decision year
Year	Clearances
1981	1
1987	1
1989	3
1994	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K935636	GRAVESPEC	HIB	Substantially Equivalent	1994-03-25
K893871	GOOTT BALFOUR BLADE	GAD	Substantially Equivalent	1989-08-03
K893869	GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)	GAD	Substantially Equivalent	1989-08-03
K893870	ADAMS BREAST IMPLANT PROTECTOR	GCZ	Substantially Equivalent	1989-07-14
K870809	MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206	GCZ	Substantially Equivalent	1987-03-19
K802806	VISECERA RETAINER	GCZ	Substantially Equivalent	1981-01-23

Registered establishments

FDA registered establishments for Adept-Med Intl., Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2918699	3000718212	ADEPT-MED INTL., INC.	665 PLEASANT VALLEY ROAD, DIAMOND SPRINGS, CA 95619 US	2026	GCZ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1156-06	Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619	Devices for which sterility may be compromised as evidenced by a loss of package integrity.		2004-08-17	Terminated

Verification record

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