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
150865–150888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1984
ENZYGNOST ROTAVIRUS AG
K841243 · LIQ
Behring Diagnostics, Inc.
Immunology · 208d
Cleared Oct 17, 1984
ASTRA 2, ASTRA 3, 4 & 6
K842394 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 120d
Cleared Oct 17, 1984
COBAS-FIBRO
K842717 · JPA
Roche Diagnostic Systems, Inc.
Hematology · 96d
Cleared Oct 17, 1984
TOXOPLASMA GONDII IGM EIA TEST KIT
K842797 · LGD
Labsystems, Inc.
Microbiology · 92d
Cleared Oct 17, 1984
ANALOX LM3 MICRO-STAT ANALYSER
K843082 · JJE
Analox Instruments , Ltd.
Chemistry · 72d
Cleared Oct 17, 1984
DACOS PLUS LYTES OPTION
K843239 · CEM
Coulter Electronics, Inc.
Pathology · 56d
Cleared Oct 17, 1984
MEDTRONIC 5984-5984LP-5985
K843837 · DXY
Medtronic Vascular
Cardiovascular · 16d
Cleared Oct 17, 1984
ULTRACLONE ECL-01-900 CELL LINE
K843862 · KIT
Earl-Clay Laboratories, Inc.
Pathology · 15d
Cleared Oct 17, 1984
ULTRACLONE ECL-01-1300 CELL LINE
K843863 · KIT
Earl-Clay Laboratories, Inc.
Pathology · 15d
Cleared Oct 17, 1984
ULTRACLONE ECL-01-1400 CELL LINE
K843864 · KIT
Earl-Clay Laboratories, Inc.
Pathology · 15d
Cleared Oct 17, 1984
DOUMENT TM LINEARITY TEST STANDARDS
K843947 · JIX
Casco Standards
Chemistry · 8d
Cleared Oct 16, 1984
TETRAFLEX INTEGRALLY SUPPORTED PTFE
K831822 · DSY
Shiley, Inc.
Cardiovascular · 497d
Cleared Oct 16, 1984
EXTENSION SET W/INJECTION SITE
K842984 · FPA
Med Fusion Systems, Inc.
General Hospital · 78d
Cleared Oct 16, 1984
UNIFLEX DANNINGER
K843309 · BXB
Buckman Co., Inc.
Physical Medicine · 54d
Cleared Oct 16, 1984
EMPTY SOLUTION TRANSFER CONTAINER 1000
K843523 · KPE
Polymer Technology Corp.
General Hospital · 39d
Cleared Oct 16, 1984
PNEUMOSCREEN
K843849 · BZC
Erich Jaeger, Inc.
Anesthesiology · 15d
Cleared Oct 15, 1984
PERCUTANEOUS CRICOTHYROIDOTOMY
K822440 · BTO
Frederic J. Toye, M.D.
Anesthesiology · 794d
Cleared Oct 15, 1984
CARDIO METRICS CARDIOTOMY RESERVOIR
K841958 · JOD
Sterile Design, Inc.
Cardiovascular · 154d
Cleared Oct 15, 1984
LIVER BIOPSY TRAY
K842001
Jayco Pharmaceuticals
Gastroenterology & Urology · 152d
Cleared Oct 15, 1984
STERILE DESIGN-CUSTOM STERILE IV KIT
K842351 · FPA
Sterile Design, Inc.
General Hospital · 122d
Cleared Oct 15, 1984
GLYCO-TEK AFFINITY COLUMN
K842689 · LCP
Helena Laboratories
Hematology · 97d
Cleared Oct 15, 1984
SAFE & SOFT MINI PADS & MAXI PADS
K842836 · HHD
Ipco Corp.
Obstetrics & Gynecology · 87d
Cleared Oct 15, 1984
SAFE & SOFT MAXI SHILEDS
K842837 · HHD
Ipco Corp.
Obstetrics & Gynecology · 87d
Cleared Oct 15, 1984
HOLLOW BASKET DENTAL IMPLANTS
K843217 · DZE
Artech Corp.
Dental · 61d