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
159649–159672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1982
CLIRANS HOLLOW FIBER DIALYZERS
K820524 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 132d
Cleared Jul 08, 1982
HANCOCK VASCULAR GRAFT
K820600 · DSY
Extracorporeal Medical Specialities,...
Cardiovascular · 126d
Cleared Jul 08, 1982
CARDIOTOMY RESERVOIRS
K820727 · DTN
Erik Perfusion Services
Cardiovascular · 113d
Cleared Jul 08, 1982
MITRAL VALVE ORIFICE SIZER
K820887 · DTI
Celtech
Cardiovascular · 100d
Cleared Jul 08, 1982
CARDI-O-LIFE MODEL 8823
K821090 · DPS
Amertek
Cardiovascular · 80d
Cleared Jul 08, 1982
INTRODUCER SET
K821188 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d
Cleared Jul 08, 1982
MULTIPURPOSE CATHETER
K821189 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d
Cleared Jul 08, 1982
XOMED PATENCY MONITOR
K821373 · DPW
Xomed, Inc.
Cardiovascular · 59d
Cleared Jul 08, 1982
NON-INVASIVE AUTOMATIC BLOOD PRESSURE
K821378 · DXN
Narco Scientific
Cardiovascular · 59d
Cleared Jul 08, 1982
MODEL TPC-1 OXYGEN ANALYZER
K821392 · CCL
Marathon
Anesthesiology · 58d
Cleared Jul 08, 1982
35MM ANGIOGRAM VIEWER ANALYZER
K821491 · DXJ
Birtcher Corp.
Cardiovascular · 51d
Cleared Jul 08, 1982
MYO/CLIP
K821518 · LDF
Alto Development Corp.
Cardiovascular · 48d
Cleared Jul 08, 1982
VITALINE DISPOSABLE EKG ELECTRODE-LEAD
K821535 · DRX
The Halverstadt Co.
Cardiovascular · 45d
Cleared Jul 08, 1982
LEVEL I CONTROL SERUM
K821557 · JJY
Irvine Scientific
Chemistry · 44d
Cleared Jul 08, 1982
TRIPLE SUGAR IRON AGAR SLANT
K821592 · JSE
Hardy Media
Microbiology · 41d
Cleared Jul 08, 1982
BILE ESCULIN AZIDE BROTH
K821593 · JSF
Hardy Media
Microbiology · 41d
Cleared Jul 08, 1982
UREA AGAR SLANT
K821594 · JSF
Hardy Media
Microbiology · 49d
Cleared Jul 08, 1982
MOTILITY TEST MEDIUM
K821595 · JSH
Hardy Media
Microbiology · 49d
Cleared Jul 08, 1982
6.5% NACL BROTH
K821596 · JSJ
Hardy Media
Microbiology · 49d
Cleared Jul 08, 1982
BRAIN HEART INFUSION
K821597 · JSC
Hardy Media
Microbiology · 49d
Cleared Jul 08, 1982
MODEL 535-02 TRACE-A-PACE TRANSMITTER
K821726 · DXH
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 08, 1982
EGG YOLK AGAR (PLATE)
K821845 · JSF
Granite Diagnostics, Inc.
Microbiology · 16d
Cleared Jul 08, 1982
COAT-A-COUNT INSULIN KIT
K821861 · CFP
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jul 08, 1982
ULTRACHEM E-GLU
K821868 · CFR
Harleco Diagnostics
Chemistry · 13d