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Medical, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Jan 25, 2011
No warning letters matched by name

Inspections 2

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 22 Latest Oct 8, 2008

Medical, Inc. has 0 FDA recalls, 2 inspections, 22 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Medical, Inc." is on file.

What these totals cover: FDA records filed under the name "Medical, Inc." and its spelling variants "Medical", "Medical Company". Records filed under related names are not included; see Related names.

Latest inspection: Jan 25, 2011 · NAI
Latest 510(k): Oct 8, 2008

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	22	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	2	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Medical, Inc. above.

Name	Relation	510(k)	Inspections	Most recent recall
Medical Center At Bowling Green	Same company group	0	5	—
Medical Center Irb	Same company group	0	1	—
Medical Center Of Aurora	Same company group	0	1	—
Medical Device Group	Same company group	1	0	—
Medical Mommas	Same company group	0	1	—

Recent FDA inspections

2 inspections from Feb 26, 2009 to Jan 25, 2011.

Date	Site	Product	Classification	FEI
Jan 25, 2011	Chantilly, VA	Devices	No Action Indicated (NAI)	1000305492
Feb 26, 2009	Chantilly, VA	Devices	No Action Indicated (NAI)	1000305492

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000305492	Chantilly, VA	2	Jan 25, 2011

Recent 510(k) clearances

22 510(k) clearances from Oct 13, 1977 to Oct 8, 2008. Showing the 20 most recent. View all 22 510(k) clearances

K-Number	Device	Date
K082311	EXSUDEX WOUND DRAINAGE PUMP	Oct 8, 2008
K926454	ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON	Jun 22, 1993
K894839	OS-1 OCCLUSION SYSTEM - 1	Oct 24, 1989
K872001	MODEL TPC-1A OXYGEN ANALYZER	Jun 15, 1987
K863806	MODEL A-1 OXYGEN ANALYZER	Oct 15, 1986
K862591	INTERFACE ARTERIAL BLOOD FILTER, MODEL 42	Sep 4, 1986
K862609	INTERFACE ARTERIAL BLOOD FILTER, MODEL 44	Sep 4, 1986
K861226	INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70	Jun 2, 1986
K851370	INTERFACE TRANSFUSION BLOOD FILTER #35	Jun 27, 1985
K823261	INTERFACE TRANSFUSION BLOOD FILTER #30	Jan 7, 1983
K823260	INTERFACE CARDIOTOMY BLOOD FILTER #51	Nov 24, 1982
K823259	INTERFACE CARDIOTOMY BLOOD FILTER #50	Nov 24, 1982
K823258	INTERFACE ARTERIAL BLOOD FILTER #40	Nov 24, 1982
K813131	INTERFACE ARTERIAL BLOOD FILTER	Nov 27, 1981
K812243	INTERFACE CARDIOTOMY BLOOD FILTER #51	Aug 25, 1981
K812244	INTERFACE PRE BYPASS PRIME FILTER #90	Aug 25, 1981
K812240	INTERFACE PRE BYPASS PRIME FILTER	Aug 25, 1981
K801451	ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM	Sep 26, 1980
K790758	HEMOCLEAR U-NEPHROS 1.0 DIALYZER	May 8, 1979
K781795	DIALYZER, PARALLEL FLOW DISPOSABLE	Dec 15, 1978

Medical, Inc. and the FDA: common questions

Has Medical, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Medical, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Medical, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Medical, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Medical, Inc.?

The most recent FDA inspection on file ended Jan 25, 2011 at Chantilly, VA and was classified NAI. FDA has 2 inspections of Medical, Inc. on file.

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