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

Filters: Cleared only ×
176,076 results
160489–160512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1982
REAL TIME ULTRASOUND SCANNER 1849
K827409
Bruel & Kjaer Instruments, Inc.
Radiology · 70d
Cleared Jul 09, 1982
MAXICAMERA MODEL 200A
K827543
General Electric Co.
Radiology · 45d
Cleared Jul 09, 1982
MOBILE DIGITAL RECEPTOR
K827571
Technicare Corp.
Radiology · 37d
Cleared Jul 09, 1982
ADAC MODEL DPS-6100 MULTI MODALITY DIGITAL PROCESING SYSTEMS
K827572
Adac Laboratories
Radiology · 38d
Cleared Jul 09, 1982
MODIFIED X-RAY TABLE
K827582
Transworld X-Ray Corp.
Radiology · 42d
Cleared Jul 09, 1982
MIDWEST AUTOMATIC BUCKY EQUIPPED WITH GRID AND SIZE-O-MATIC TRAY
K827609
Midwest X-Ray Equipment Co.
Radiology · 31d
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