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
175489–175512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1976
NEGATIVE CONTROL SERUM
K760836
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
HEXCELITE SHEET SPLINTS
K760841 · ITG
Hexcel Medical
Physical Medicine · 19d
Cleared Nov 01, 1976
CONCHA-COLUMN
K760866 · BTT
Respiratory Care, Inc.
Anesthesiology · 14d
Cleared Nov 01, 1976
VEST RESTRAINT
K760868 · KNW
Orthopedic Equipment Co., Inc.
Gastroenterology & Urology · 14d
Cleared Nov 01, 1976
SPLIT CERVICAL COLLAR/HEAD HALTER
K760869 · HSS
Orthopedic Equipment Co., Inc.
Physical Medicine · 14d
Cleared Nov 01, 1976
HEEL/ELBOW FLOTATION CUSHION
K760870 · FMP
Medpro, Inc.
General Hospital · 14d
Cleared Oct 29, 1976
MONITOR, CITADEL INTRAVASCULAR PO2
K760350 · CCE
Sherwood Medical Industries
Anesthesiology · 88d
Cleared Oct 29, 1976
CRYOLYZER ALPHA
K760353 · GEH
Pilling Co.
General & Plastic Surgery · 88d
Cleared Oct 29, 1976
REAGENT, MAGNESIUM CHLORIDE
K760398 · CJE
J.T. Baker Chemical Co.
Chemistry · 84d
Cleared Oct 29, 1976
CAFFEINE DILUENT
K760406 · CIG
J.T. Baker Chemical Co.
Chemistry · 81d
Cleared Oct 29, 1976
SULFANILIC ACID
K760407 · CIG
J.T. Baker Chemical Co.
Chemistry · 81d
Cleared Oct 29, 1976
AMP BUFFER
K760410 · CFJ
J.T. Baker Chemical Co.
Chemistry · 81d
Cleared Oct 29, 1976
NAD (SPOONPAK CONTAINER)
K760411 · CFJ
J.T. Baker Chemical Co.
Chemistry · 81d
Cleared Oct 29, 1976
LIPID CONTROL
K760449 · JJX
Sigma Chemical Co.
Chemistry · 74d
Cleared Oct 29, 1976
ROTATOR, FIXED SPEED
K760467 · JQC
Lederle Laboratories
Chemistry · 72d
Cleared Oct 29, 1976
INSTRUMENTED SYSTEM FOR URINALYSIS
K760472 · KQO
Miles Laboratories, Inc.
Chemistry · 71d
Cleared Oct 29, 1976
REAGENT, ALBUMIN DETERMINATION
K760473 · CIX
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, ALKALINE PHOSPHATASE DETERM.
K760474 · CJE
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, CALCIUM DETERMINATION
K760475 · CIC
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENTS-4 FOR URIC ACID DETERMINATION
K760477 · CDH
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, BUN (UREA NITROGEN) DETERM.
K760478 · CDW
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, TOTAL BILIRUBIN DETERMINATION
K760479 · CIG
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, TOTAL PROTEIN DETERMINATION
K760480 · CEK
Simmler & Son, Inc.
Chemistry · 73d
Cleared Oct 29, 1976
REAGENT, PARTIAL THROMBOPLASTIN
K760499
Hyland Therapeutic Div., Travenol...
Cardiovascular · 67d