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
163105–163128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1981
ULTRA CHEM E-GLU #64976 & 65040
K812595 · CFR
Harleco
Chemistry · 18d
Cleared Sep 29, 1981
ULTRA ZYME PLUS ALP #64962, 65029 & 30
K812596 · CJE
Harleco
Chemistry · 18d
Cleared Sep 29, 1981
RABBIT COAGULASE PLASMA
K812602 · JTL
Dutchland Laboratories, Inc.
Microbiology · 14d
Cleared Sep 29, 1981
ACA PLASMINOGEN TEST PACK
K812625 · DDX
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN G CALIBRATOR
K812630 · DEW
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN A TEST PACK
K812631 · CZP
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN M TEST PACK
K812632 · DFT
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN A/M CALIBRATORS
K812633 · CZP
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
EHTOX GASTRIC LAVAGE KIT #2050 & #2070
K812648 · KNT
Ethox Corp.
Gastroenterology & Urology · 12d
Cleared Sep 29, 1981
CEA CONTROL PLASMA
K812658 · DHX
Pacific Hemostasis
Immunology · 11d
Cleared Sep 29, 1981
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
K812661 · DFH
Dako Corp.
Immunology · 11d
Cleared Sep 29, 1981
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
K812662 · DEH
Dako Corp.
Immunology · 11d
Cleared Sep 29, 1981
AFB STAIN SET
K812668 · JTS
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 8d
Cleared Sep 29, 1981
ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE
K812685 · FJK
Ericka
Gastroenterology & Urology · 7d
Cleared Sep 28, 1981
A.D.T. PROCEDURES TRAY
K812297 · KMJ
A.D.T. Lab Industries
General Hospital · 45d
Cleared Sep 25, 1981
SPIROMETER 210/211
K812039 · BZG
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 66d
Cleared Sep 25, 1981
VENTI-MONITOR MODEL 101
K812041 · CAP
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 66d
Cleared Sep 25, 1981
CENTERAL MONITOR 360
K812144 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-3
K812145 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-5
K812146 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-7
K812147 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
DISPOSABLE ELECTRODE, #1610
K812276 · DRX
Andover Medical, Inc.
Cardiovascular · 43d
Cleared Sep 25, 1981
FLOW-DIRECTED THERMODILUTION CATHETER
K812324 · DYG
Sorensen Research
Cardiovascular · 39d
Cleared Sep 25, 1981
SORENSON SUBCLAVIAN CATHETER SSC-8
K812326 · LFJ
Sorensen Research
Gastroenterology & Urology · 39d