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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145777–145800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1986
TOTAL PROTEIN (BIURET) REAGENT SET
K860341 · CEK
Sterling Diagnostics, Inc.
Chemistry · 13d
Cleared Feb 11, 1986
ALKALINE PHOSPHATASE REAGENT SET
K860351 · CIO
Sterling Diagnostics, Inc.
Chemistry · 12d
Cleared Feb 11, 1986
CREATININE REAGENT SET
K860418 · CGX
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared Feb 11, 1986
UREA NITROGEN REAGENT SET
K860419 · CDW
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared Feb 11, 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
K860421 · CDX
American Dade
Chemistry · 7d
Cleared Feb 10, 1986
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500
K854406 · JQW
Tecan U.S., Ltd.
Chemistry · 101d
Cleared Feb 10, 1986
STUART GILMAN'S WEIGHT LOSS PLAN
K854441 · LDQ
Alpha Therapeutic Corp.
General & Plastic Surgery · 97d
Cleared Feb 10, 1986
LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM
K854465 · JDI
Link America, Inc.
Orthopedic · 96d
Cleared Feb 10, 1986
VENOUS RETURN CANNULA W/CUFF 91039
K854487 · DWF
Dlp, Inc.
Cardiovascular · 94d
Cleared Feb 10, 1986
ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET
K854511 · DQX
Electro-Catheter Corp.
Cardiovascular · 90d
Cleared Feb 10, 1986
DEMAND FLOW VALVE & SONRA W/NASAL MASK
K854571 · CBN
Gale E. Dryden
Anesthesiology · 88d
Cleared Feb 10, 1986
MODIFIED CORONARY CARDIOPLEGIA ADAPTOR
K854640 · DWF
Shiley, Inc.
Cardiovascular · 83d
Cleared Feb 10, 1986
ANGIOMED URETERAL STONE DISLODGERS
K854652 · FFL
Angiomed U.S., Inc.
Gastroenterology & Urology · 83d
Cleared Feb 10, 1986
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
K854734 · DRM
Medasonics, Inc.
Cardiovascular · 77d
Cleared Feb 10, 1986
SHILEY VENOUS RESERVOIR
K854841 · DTN
Shiley, Inc.
Cardiovascular · 68d
Cleared Feb 10, 1986
MA-1 VOLUME VENTIALTOR
K854843
Puritan Bennett Corp.
Cardiovascular · 68d
Cleared Feb 10, 1986
CURITY URETERAL STENT
K854862 · FAD
The Kendal Co.
Gastroenterology & Urology · 67d
Cleared Feb 10, 1986
DISPOSABLE MANIFOLD
K854960 · DTL
Utah Medical Products, Inc.
Cardiovascular · 61d
Cleared Feb 10, 1986
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · KNW
Travenol Laboratories, S.A.
Gastroenterology & Urology · 59d
Cleared Feb 10, 1986
HYDRAJUST III UROLOGICAL TABLE
K860040 · KQS
Mallinckrodt Group, Inc.
Gastroenterology & Urology · 35d
Cleared Feb 10, 1986
URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE
K860143 · JJP
Reagent Laboratory, Inc.
Chemistry · 26d
Cleared Feb 07, 1986
VITREONIC PLUS
K834160 · HQE
American Surgical Co., Inc.
Ophthalmic · 847d
Cleared Feb 07, 1986
VIT PAC
K834162 · HQE
American Surgical Co., Inc.
Ophthalmic · 847d
Cleared Feb 07, 1986
VISITHERM
K852950 · IYM
C.D. Regelin & Associates, Inc.
Radiology · 211d