Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
165001–165024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1981
STERILE WET DRESSING PACK
K810406
W.G. Whitney Corp.
General & Plastic Surgery · 21d
Cleared Mar 11, 1981
NARCO TLECARE MINIATURE PRESSURE DOME
K810431 · DRS
Narco Bio-Systems
Cardiovascular · 20d
Cleared Mar 11, 1981
BURRON PERCUTANEOUS INDUCER SET
K810460 · DQY
Burron Medical Products, Inc.
Cardiovascular · 19d
Cleared Mar 11, 1981
BURRON CENTRAL VEIN CATHERIZATION KIT
K810461 · DQY
Burron Medical Products, Inc.
Cardiovascular · 19d
Cleared Mar 11, 1981
PHADEZYM RAST TEST
K810462 · DHB
Pharmacia, Inc.
Immunology · 19d
Cleared Mar 11, 1981
DCA DIGOX-SYN RIA TEST
K810477 · DOG
Diagnostic Corp. of America
Toxicology · 16d
Cleared Mar 11, 1981
VISUAL PATTERN REVERSAL GEN. & PHOTIC S.
K810481 · GWE
Amplaid USA, Inc.
Neurology · 16d
Cleared Mar 11, 1981
FALLOPIAN TUBE FORCEPS
K810483 · KNA
American V. Mueller
Obstetrics & Gynecology · 16d
Cleared Mar 11, 1981
OVARY FORCEPS
K810484 · KNA
American V. Mueller
Obstetrics & Gynecology · 16d
Cleared Mar 11, 1981
BONE FIXACTION SCREW
K810497 · HWC
Serrano Intl.
Orthopedic · 15d
Cleared Mar 11, 1981
THERACHEM ANTI CONVULSANTA THEOPHYLLINE
K810504 · DIF
Fisher Scientific Co., LLC
Toxicology · 15d
Cleared Mar 11, 1981
CIRCLE NEPHROSTOMY TUBE INTRODUCER
K810533 · KOA
American V. Mueller
Gastroenterology & Urology · 13d
Cleared Mar 11, 1981
GEMENI QUICK-MB SEPARATION KIT
K810534 · JHT
Gemini, Inc.
Chemistry · 13d
Cleared Mar 11, 1981
AUTOMATIC SCREENING AUDIOMETER
K810537 · EWO
Positron
Ear, Nose, Throat · 13d
Cleared Mar 11, 1981
INCONTINENT PAD & BELT
K810544 · EYQ
Principle Business Ent.
Gastroenterology & Urology · 12d
Cleared Mar 11, 1981
BLSI VENTILATION MONITOR
K810547 · CAP
Bunnell Life Systems, Inc.
Anesthesiology · 9d
Cleared Mar 11, 1981
NEOCARE OXYGEN MONITOR
K810571 · CCL
Vickers America Medical Corp.
Anesthesiology · 8d
Cleared Mar 10, 1981
MBI-4
K810247 · IPF
Bloomex International, Inc.
Physical Medicine · 40d
Cleared Mar 09, 1981
ELA MEDICAL PACING LEAD MODEL PMA 860
K810626
Ela Medical, Inc.
Cardiovascular
Cleared Mar 06, 1981
COPPER SULFATE SOLUTION SP. GR.1.053
K803094 · KLS
Accra Laboratories, Inc.
Hematology · 88d
Cleared Mar 06, 1981
COPPER SULFATE SOLUTION SP. GR.1.055
K803095 · KSL
Accra Laboratories, Inc.
Hematology · 88d
Cleared Mar 06, 1981
SKIN BEAUTY CLEANSER & TONER
K803314 · IPF
Dynex International, Ltd.
Physical Medicine · 67d
Cleared Mar 06, 1981
DAC-CEL DIAGNATAL
K810214 · JHI
Burroughs Wellcome Co.
Chemistry · 38d
Cleared Mar 06, 1981
CONDYLAR KNEE W/METAL ENCAPSULATED TIB
K810230 · HRY
Hexcel Medical
Orthopedic · 38d