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
146713–146736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1985
H-H CATHETER PASSERS(TACL DESIGN
K853370 · GYK
Holter-Hausner Intl.
Neurology · 37d
Cleared Sep 18, 1985
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS
K853371 · JXG
Holter-Hausner Intl.
Neurology · 37d
Cleared Sep 18, 1985
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
K853548 · LCM
American Dade
Chemistry · 23d
Cleared Sep 18, 1985
SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY
K853628 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared Sep 17, 1985
REVIVE SYSTEM
K844445 · LKY
Revive Systems Corp.
Gastroenterology & Urology · 305d
Cleared Sep 17, 1985
TELEFLEX GUIDEWIRE
K850677 · DQX
Teleflexmedical, Inc.
Cardiovascular · 208d
Cleared Sep 17, 1985
SONOLAYER-V, SSA-90A
K851036 · ITX
Toshiba Medical Systems
Radiology · 188d
Cleared Sep 17, 1985
SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664
K851220 · KFZ
Northern Electric Co. Div. of Sunbeam...
Anesthesiology · 175d
Cleared Sep 17, 1985
BARD-PARKER OCCLUSION BALLOON CATHETER
K852294 · DYG
Bd Becton Dickinson Vacutainer...
Cardiovascular · 111d
Cleared Sep 17, 1985
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
K852371 · GKZ
Abbott Diagnostics
Hematology · 105d
Cleared Sep 17, 1985
ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP
K852446 · DTB
Diag Corp.
Cardiovascular · 99d
Cleared Sep 17, 1985
ABBOTT RSV EIA
K852472 · LKT
Abbott Laboratories
Microbiology · 98d
Cleared Sep 17, 1985
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
K852512 · GHH
Pacific Hemostasis
Hematology · 97d
Cleared Sep 17, 1985
IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A
K852709 · DTB
Telectronics, Inc.
Cardiovascular · 83d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401
K853221 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402
K853222 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407
K853223 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 17, 1985
COLUMBIZ BLOOD AGAR
K853690 · JSG
Micro Media Laboratories
Microbiology · 13d
Cleared Sep 17, 1985
TERGITOL 7 AGAR
K853691 · JSI
Micro Media Laboratories
Microbiology · 13d
Cleared Sep 16, 1985
SURGICAL ASPIRATOR
K850946 · BTA
Medicalex
General & Plastic Surgery · 193d
Cleared Sep 16, 1985
FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM
K851450 · JIW
Flow Cytometry Standards Corp.
Microbiology · 158d
Cleared Sep 16, 1985
CARBOCONE
K851732 · DRX
Imtech Corp.
Cardiovascular · 144d
Cleared Sep 16, 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · LDF
Cordis Corp.
Cardiovascular · 138d
Cleared Sep 16, 1985
HEMATOCRIT-SATURATION MONITOR HSM-100
K852124 · DRY
American Bentley
Cardiovascular · 124d