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
170713–170736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1979
STIMULATOR, BATTERY POWERED
K790123 · BXN
Intermedics, Inc.
Anesthesiology · 14d
Cleared Feb 06, 1979
MASK, PERCENTO
K790146 · BYF
Airlife, Inc.
Anesthesiology · 25d
Cleared Feb 06, 1979
OXYGEN MASK REBREATHER
K790164 · BYG
Airlife, Inc.
Anesthesiology · 25d
Cleared Feb 06, 1979
OXYGEN MASK-HIGH CONCENTRATION
K790165 · BYG
Airlife, Inc.
Anesthesiology · 25d
Cleared Feb 06, 1979
GENERATOR, MODEL VG-1
K790217 · GWE
Street Electronics Corp.
Neurology · 7d
Cleared Feb 05, 1979
CANNULAS, DYNACOR'S NASAL OXYGEN
K790056 · CAT
Medline Industries, Inc.
Anesthesiology · 27d
Cleared Feb 05, 1979
CATHETER, OXYGEN
K790057 · BZB
Medline Industries, Inc.
Anesthesiology · 27d
Cleared Feb 05, 1979
DRILL, CORDLESS SURGICAL
K790063 · KIJ
Richard'S Medical Equip., Inc.
Orthopedic · 21d
Cleared Feb 02, 1979
FLEXT-THERM
K781916 · KXZ
E-Z-Em, Inc.
Radiology · 80d
Cleared Feb 01, 1979
VERTETRAC
K771988 · HST
Ballert Orthopedic Corp.
Neurology · 470d
Cleared Feb 01, 1979
LIFELINE PACING LEAD MODEL 465-01
K781497 · DTB
Intermedics, Inc.
Cardiovascular · 155d
Cleared Feb 01, 1979
LIFELINE BIPOLAR PACING LEAD MOD. 466-01
K781498 · DTB
Intermedics, Inc.
Cardiovascular · 155d
Cleared Feb 01, 1979
LIFELINE PACING LEAD MODEL 467-01
K781499 · DTB
Intermedics, Inc.
Cardiovascular · 155d
Cleared Feb 01, 1979
ENDOCARIDAL PACING LEAD UNIPOLAR 477
K781525 · DTB
Intermedics, Inc.
Cardiovascular · 149d
Cleared Feb 01, 1979
SUTURELESS MUOCARDINE PACING LEADS 471
K781570 · DTB
Intermedics, Inc.
Cardiovascular · 140d
Cleared Feb 01, 1979
PANT LINER, DISP. INCONTINENT
K781930 · EYQ
Fibre Formations, Inc.
Gastroenterology & Urology · 78d
Cleared Feb 01, 1979
RIA KIT, IMMO PHASE
K781953 · JLW
Corning Medical & Scientific
Chemistry · 72d
Cleared Feb 01, 1979
A-GENT CK-MB
K782015 · JHW
Abbott Laboratories
Chemistry · 58d
Cleared Feb 01, 1979
REAGENT, COCCI LATEX
K782070 · GMG
I M, Inc.
Microbiology · 51d
Cleared Feb 01, 1979
ELECTRODE SYSTEM, QUIK-PREP
K782079 · DRX
Quinton, Inc.
Cardiovascular · 50d
Cleared Feb 01, 1979
EMIT THYROXINE ASSAY
K782085 · KLI
Syva Co.
Chemistry · 49d
Cleared Feb 01, 1979
AM-PEN SCREEN
K782086 · JTO
Pfizer, Inc.
Microbiology · 49d
Cleared Feb 01, 1979
ASTRA-VAC
K782115 · GCY
Ab Astra
General & Plastic Surgery · 36d
Cleared Feb 01, 1979
MARTIN-LEWIS MEDIUM
K782117 · JTY
Prepared Media Laboratory, Inc.
Microbiology · 36d