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
158617–158640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1982
ANGIOUROGRAPHY KIT
K822159 · FMF
Mallinckrodt Critical Care
General Hospital · 103d
Cleared Nov 03, 1982
EXTRACORPOREAL SINGLE NEEDLE MODULE
K822340 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 91d
Cleared Nov 03, 1982
MONAGHAN AEROCHAMBER
K822437 · BYP
Monaghan Medical Corp.
Anesthesiology · 82d
Cleared Nov 03, 1982
OBTURATION GUTTA
K822464 · EKA
U.S. Shizai Corp.
Dental · 79d
Cleared Nov 03, 1982
DEVICE FOR THE TREATMENT OF HEMORRHOIDS
K822649 · LKX
Dunmore Corp.
Gastroenterology & Urology · 63d
Cleared Nov 03, 1982
ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
K822711 · FAX
Parker Laboratories, Inc.
Gastroenterology & Urology · 57d
Cleared Nov 03, 1982
#ST10 PROGR. EVOKED RESPONSE STIMULATOR
K822744 · GWF
Teca, Inc.
Neurology · 54d
Cleared Nov 03, 1982
9110 SYRINGE
K822774 · FMF
Cardiac Pacemakers, Inc.
General Hospital · 50d
Cleared Nov 03, 1982
INFUS. SETS-9120-50 CM & 9121-100 CM,EXT
K822775 · FPA
Cardiac Pacemakers, Inc.
General Hospital · 50d
Cleared Nov 03, 1982
TEFLON CANNULA
K822776 · FOZ
Cardiac Pacemakers, Inc.
General Hospital · 50d
Cleared Nov 03, 1982
LIFELINE 4800-C DIGITAL SPIROMETER
K822861 · BZG
Lifeline Controls
Anesthesiology · 37d
Cleared Nov 03, 1982
HOLTER RECORDER
K822970 · DSH
Agilent Technologies
Cardiovascular · 26d
Cleared Nov 03, 1982
HARVARD APPARATUS SINGLE SPEED SYRINGE
K822989 · FRN
C.R. Bard, Inc.
General Hospital · 22d
Cleared Nov 03, 1982
NOVAREX
K823008 · EJH
Jeneric Ind.
Dental · 22d
Cleared Nov 03, 1982
THE INGLEFIELD MAGIC RING
K823056 · FMF
The Inglefield Co.
General Hospital · 16d
Cleared Nov 01, 1982
SARNS PULSATILE PUMP
K820729 · DWB
3M Health Care, Sarns
Cardiovascular · 229d
Cleared Nov 01, 1982
WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD
K821477 · DTZ
C.R. Bard, Inc.
Cardiovascular · 167d
Cleared Nov 01, 1982
CNIBP BLOOD PRESSURE MEASUREMENT SYS
K822055 · DXN
Ohio Medical Products
Cardiovascular · 111d
Cleared Nov 01, 1982
TITAN GEL CPK ISOENZYME SYSTEM
K822124 · JHT
Helena Laboratories
Chemistry · 105d
Cleared Nov 01, 1982
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 84d
Cleared Nov 01, 1982
CENTURION CHART RECORDER
K822432 · DSF
Clinical Data, Inc.
Cardiovascular · 81d
Cleared Nov 01, 1982
CYTOMEGALOVIRUS ANTOBODY IGG
K822606 · LIN
Immulok, Inc.
Microbiology · 66d
Cleared Nov 01, 1982
MEDI-TRACE 5' OFFSET ELECTRODE
K822750 · DRX
Graphic Controls Corp.
Cardiovascular · 49d
Cleared Nov 01, 1982
BLOOD OXYGENATORS #BOS-105S BOS-5S W/
K822803 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 45d