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
155977–156000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1983
RESPIR GARD BACTERIA FILTER
K833269 · CAH
Marquest Medical Products, Inc.
General Hospital · 40d
Cleared Oct 31, 1983
MASSON TRICHROME STAIN HT15
K833273 · ICN
Sigma Chemical Co.
Pathology · 40d
Cleared Oct 31, 1983
LEIDER FEEDING TUBE W/HYDROMER LUBR
K833293 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 39d
Cleared Oct 31, 1983
WESCOR 7100 AEROSPRAY SLIDE STAINER
K833295 · KPA
Wescor, Inc.
Hematology · 38d
Cleared Oct 31, 1983
SCHULTZ ENDHOLD
K833332 · JAY
Polyclinic Medical Center
Anesthesiology · 34d
Cleared Oct 31, 1983
IRON STAIN PROCEDURE HT20
K833388 · LED
Sigma Chemical Co.
Pathology · 33d
Cleared Oct 28, 1983
AUGROS HYSTEROMETER
K831224 · HHM
Axcan Scientific Corp.
Obstetrics & Gynecology · 196d
Cleared Oct 28, 1983
ELECTRONEURAL STIMULATOR 12
K831487 · GZJ
Meridia 12 Corp.
Neurology · 171d
Cleared Oct 28, 1983
CRITIKON CARDIAC OUTPUT COMPUTER
K831967 · DXG
Critikon Company, LLC
Cardiovascular · 130d
Cleared Oct 28, 1983
HEMOCUE PHOTOMETER TECHNICAL MANUAL
K832020 · GKR
Aktiebolaget Leo Diagnostics
Hematology · 135d
Cleared Oct 28, 1983
AMES TDA NETILMICIN TEST & SERUM
K832088 · LCE
Miles Laboratories, Inc.
Chemistry · 122d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
K832257 · CZN
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN IGM H CHAIN
K832259 · DFT
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN LAMBA AFFINITY
K832261 · DEH
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
FITC GOAT ANTI-HUMAN IGG Y CHAIN
K832264 · DEW
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
CRASH CART
K832355 · BZN
Quinton, Inc.
Anesthesiology · 102d
Cleared Oct 28, 1983
PORTABLE OPERAT. RM. MONITORS HS30/40
K832356 · BZN
Medtel Pty. , Ltd.
Anesthesiology · 102d
Cleared Oct 28, 1983
VERIMED MYOEXORCISER
K832714 · HCC
Verimed Holdings, Inc.
Neurology · 77d
Cleared Oct 28, 1983
ERYTHROCYTE TEST
K832771 · LKZ
Bio-Analytics Laboratories, Inc.
Hematology · 73d
Cleared Oct 28, 1983
AGAR 8000 TENS
K832851 · GZJ
Kimed Industries, Inc.
Neurology · 67d
Cleared Oct 28, 1983
B-SLIDE PREGNATE PREGNANCY TEST KIT
K832879 · JHJ
Fisher Scientific Co., LLC
Chemistry · 63d
Cleared Oct 28, 1983
MODIFIED CHORIO-SHURE
K832892 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 63d
Cleared Oct 28, 1983
ENZYMATIC GLUCOSE DETERMINATION
K832926 · CGA
Seragen Diagnostics, Inc.
Chemistry · 70d
Cleared Oct 28, 1983
BUN LIQUID STABLE REAGENT SET
K832941 · CDQ
Medical Analysis Systems, Inc.
Chemistry · 59d