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
168385–168408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1980
POLY-LEC SYSTEM
K792582 · KSI
Gamma Biologicals, Inc.
Hematology · 33d
Cleared Jan 16, 1980
GAMMA ARACHIS HYPOGEA LECTIN
K792583 · KSI
Gamma Biologicals, Inc.
Hematology · 33d
Cleared Jan 16, 1980
TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY
K792599 · CDX
Nuclear Diagnostics, Inc.
Chemistry · 29d
Cleared Jan 16, 1980
CHLORIDE REAGENT
K792605 · CHJ
Gilford Diagnostics
Chemistry · 29d
Cleared Jan 16, 1980
T3 UPTAKE (T3U) REAGENTS
K792607 · KHQ
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 29d
Cleared Jan 16, 1980
STERILIZATION PROCESS/PLACENTA BASIN
K792625 · FNY
Procter & Gamble Mfg. Co.
General Hospital · 28d
Cleared Jan 16, 1980
STERILIZATION PROCESS/BABY BLANKET
K792626 · KME
Procter & Gamble Mfg. Co.
General Hospital · 28d
Cleared Jan 16, 1980
STERILIZATION PROCESS/BULB SYRINGE
K792632
Procter & Gamble Mfg. Co.
Dental · 28d
Cleared Jan 16, 1980
CONCEPTROL/THIN PROPHYLACTICS
K792634 · HIS
Ortho Pharmaceutical Corp.
Obstetrics & Gynecology · 28d
Cleared Jan 16, 1980
LEECO P.A.P. QUANT. DIAGNOSTIC KIT
K792652 · JFH
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Jan 16, 1980
SENSI-SLIDE
K792657 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jan 16, 1980
LEUKOPOR
K792666 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 20d
Cleared Jan 16, 1980
LEUKOCLIP POROS
K792667 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 20d
Cleared Jan 16, 1980
3 WAY URETHRAL IRRIGATION CATHETER
K792719 · KOD
Vesta, Inc.
Gastroenterology & Urology · 19d
Cleared Jan 11, 1980
ENTERIC-TEK
K792058 · JSS
Flow Laboratories, Inc.
Microbiology · 88d
Cleared Jan 11, 1980
RUBELISA TEST KIT
K792133 · GOK
Microbiological Assoc.
Microbiology · 81d
Cleared Jan 11, 1980
DYE CURVE EVALUATOR
K792135 · DQK
Sci-Pro, Inc.
Cardiovascular · 81d
Cleared Jan 11, 1980
CHEMISTRY ANALYZER REAGENTS
K792482 · CIX
Laboratory Products, Inc.
Chemistry · 53d
Cleared Jan 11, 1980
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
K792509 · CHH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Jan 11, 1980
SANDARE CHLORIDE PROCEDURE
K792531 · CHJ
Sandare Chemical Co., Inc.
Chemistry · 35d
Cleared Jan 11, 1980
GLUCOSE (HEXOKINASE) REAGENT SET
K792532 · CFR
Macomb Chemical Co.
Chemistry · 35d
Cleared Jan 11, 1980
CREATINE PHOSPHOKINASE (CPK) REAGENT SET
K792533 · JHW
Macomb Chemical Co.
Chemistry · 35d
Cleared Jan 11, 1980
THROMBOKINETIC FIBRINOGEN ASSAY
K792563 · KQJ
Bio/Data Corp.
Hematology · 30d
Cleared Jan 11, 1980
CULTURIA MACCONKEY/COLUMBIA CNA
K792579 · JXA
Clinical Convenience Products, Inc.
Microbiology · 28d