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
165433–165456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1981
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
K803219 · GKZ
Abbott Laboratories
Microbiology · 33d
Cleared Jan 21, 1981
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
K803278 · CEP
Immuno Nuclear Corp.
Chemistry · 23d
Cleared Jan 21, 1981
'NO-BOIL' FOLIC ACID KIT
K810003
Diagnostic Products Corp.
Chemistry · 15d
Cleared Jan 21, 1981
CORTI-SHURE
K810033 · CGR
Nuclear Medical Laboratories, Inc.
Chemistry · 15d
Cleared Jan 16, 1981
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
K801771 · LGL
Isolab, Inc.
Hematology · 172d
Cleared Jan 16, 1981
DIALYIS START CARE KIT
K802361 · FKG
Med-Pak Corp.
Gastroenterology & Urology · 112d
Cleared Jan 16, 1981
DISPOSABLE GAS LINE FILTER
K802539 · KRI
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE PARALLEL Y CONNECTORS
K802541 · KRI
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE CONNECTORS
K802542 · KRI
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
RIDGID VENA CAVA CANNULAE
K802543 · DWF
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE QUICK RELEASE PERFUSION ADAP
K802544 · DTL
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
CARDIOPLEGIC SETS
K802545 · DTR
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
PERMANENT & TEMP. PACEMAKER ELECTRODE
K802547 · DTB
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE
K802552 · DTB
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN
K802553 · DTB
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
ENDOCARDIAL LEADS 414S & 515S
K802816 · DTB
Siemens Elema AB
Cardiovascular · 70d
Cleared Jan 16, 1981
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K802832 · LCP
Sandare Chemical Co., Inc.
Hematology · 65d
Cleared Jan 16, 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802917 · DXK
Advanced Technology Laboratories, Inc.
Cardiovascular · 58d
Cleared Jan 16, 1981
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
K803058 · LDF
American Edwards Laboratories
Cardiovascular · 45d
Cleared Jan 16, 1981
SYRINGE FOR BLOOD SAMPLING
K803182 · GIM
The University of Chicago
Hematology · 31d
Cleared Jan 16, 1981
THB 6000 HARDSHELL BUBBLE OXYGENATOR
K803231 · DTZ
Travenol Laboratories, S.A.
Cardiovascular · 25d
Cleared Jan 16, 1981
AUTOMATED IMMUOCHEMISTRY SYSTEM
K803267 · JJE
Beckman Instruments, Inc.
Chemistry · 18d
Cleared Jan 16, 1981
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273 · CFT
Corning Medical & Scientific
Chemistry · 18d
Cleared Jan 16, 1981
FOLLICE STIMULATING HORMONE-RADIOIMM. KT
K803279 · CGJ
Immuno Nuclear Corp.
Chemistry · 18d