Amphenol Critical Medical Technologies, LLC

San Diego, CA, US

Amphenol Critical Medical Technologies, LLC appears in FDA device records in San Diego, CA. FDA records list one 510(k) clearance, 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: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Amphenol Critical Medical Technologies, LLC 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.

Integra Biotechnical, LLC510(k), recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Amphenol Critical Medical Technologies, LLC in 1998.

Clearances by year, as a table

510(k) clearance decisions for Amphenol Critical Medical Technologies, LLC, by decision year
Year	Clearances
1998	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K983073	I.V. EXTENSION SET OR I.V. ADMINISTRATION SET	FPA	Substantially Equivalent	1998-12-16

Registered establishments

FDA registered establishments for Amphenol Critical Medical Technologies, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2030116	1000519289	Amphenol Critical Medical Technologies, LLC	9586 Distribution Avenue, Suite F, San Diego, CA 92121 US	2026	No device listings on this registration

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

FDA product codes

FPASet, Administration, Intravascular

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0714-2007	ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625	During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.		2007-02-01	Terminated

Verification record

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