FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164593–164616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 16, 1981
HUMAN GROWTH HORMONE-RADIOIMM. KIT
K803280 · CFL
Immuno Nuclear Corp.
Chemistry · 18d
Cleared Jan 16, 1981
AUTOMATED ELECTROPHORESIS SYSTEM
K803281 · JJN
Helena Laboratories
Chemistry · 18d
Cleared Jan 16, 1981
PHOTOMETER
K803285 · JJQ
Turner Designs, Inc.
Chemistry · 17d
Cleared Jan 16, 1981
CHOLESTEROL REAGENT ENZYMATIC
K803287 · CHH
Rai, Inc.
Chemistry · 17d
Cleared Jan 16, 1981
ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT
K803296 · KWW
Immunotech Corp.
Chemistry · 17d
Cleared Jan 16, 1981
LUQUIZYME TRIGLYCERIDE REAGENT SET
K803297 · CDT
Amresco, Inc.
Chemistry · 17d