FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"

3001–3024 of 5,198

Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital

Cleared Aug 27, 2003

KENTEX DISPOSABLE VAGINAL SPECULUM

Kentron Health Care, Inc.

Obstetrics & Gynecology · 175d

Cleared Aug 19, 2003

SYNDEO PCA SYRINGE PUMP, MODEL 2L3113

Baxter Healthcare Corp

General Hospital · 92d

Cleared Aug 12, 2003

AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS

Viasys Healthcare, Inc.

Ear, Nose, Throat · 71d

Cleared Aug 06, 2003

TOX AMMONIA CALIBRATOR

Bayer Healthcare, LLC

Chemistry · 68d

Cleared Aug 01, 2003

BALL RECORDING ELECTRODE/STIMULATION PROBE

Viasys Healthcare, Inc.

Neurology · 163d

Cleared Aug 01, 2003

HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II

Hygia Health Services, Inc.

Anesthesiology · 717d

Cleared Jul 31, 2003

NICHOLS ADVANTAGE ALDOSTERONE ASSAY

Nichols Institute Diagnostics

Chemistry · 14d

Cleared Jul 30, 2003

Viasys Healthcare GmbH

Anesthesiology · 105d

Cleared Jul 07, 2003

RESPIRATORY HUMIDIFIER, MODEL MR850

Fisher &Paykel Healthcare , Ltd.

Anesthesiology · 522d

Cleared Jul 01, 2003

Health & Life Co., Ltd.

Cardiovascular · 29d

Cleared Jul 01, 2003

Health & Life Co., Ltd.

Cardiovascular · 29d

Cleared Jun 25, 2003

LIPOPROTEIN CALIBRATOR

Bayer Healthcare, LLC

Chemistry · 26d

Cleared Jun 25, 2003

BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL

Bayer Healthcare, LLC

Chemistry · 29d

Cleared Jun 24, 2003

BAYER ADVIA CENTAUR CA 19-9 ASSAY

Bayer Healthcare, LLC

Immunology · 53d

Cleared Jun 23, 2003

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

Bayer Healthcare, LLC

Chemistry · 83d

Cleared Jun 20, 2003

TEMPORARY TITANIUM ANEURYSM CLIP

Neurology · 42d

Cleared Jun 17, 2003

BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000

Baxter Healthcare Corp

Gastroenterology & Urology · 158d

Cleared Jun 12, 2003

SINGLE USE ORAL MASK, MODEL HC455A

Fisher &Paykel Healthcare , Ltd.

Anesthesiology · 224d

Cleared Jun 12, 2003

FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK

Fisher &Paykel Healthcare , Ltd.

Anesthesiology · 232d

Cleared Jun 11, 2003

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER

The Kendall Company Div. of Tyco...

Gastroenterology & Urology · 189d

Cleared Jun 10, 2003

KLINIDRAPE SURGICAL DRAPES

Molnlycke Health Care

General Hospital · 62d

Cleared Jun 05, 2003

PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US

Tyco Healthcare Nancy

Anesthesiology · 27d

Cleared May 30, 2003

EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP

S-Tct Health, Inc.

Cardiovascular · 94d

Cleared May 20, 2003

BODY CLOCK TENS N' TONE

Body Clock Health Care, Ltd.

Neurology · 266d