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
166489–166512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1980
REAGENT FOR DETERM. POTASSIUM/IN HUMAN
K800692 · CEM
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
AUTOFLUOR SYSTEM
K800698 · JZT
California Immuno Diagnostic, Inc.
Immunology · 61d
Cleared May 28, 1980
BITE BLOCK SYSTEM
K800760
Radiation Products Design, Inc.
Neurology · 54d
Cleared May 28, 1980
PACE-PULSE/COMPUTRAC
K800782 · KRE
Bib, Inc.
Cardiovascular · 50d
Cleared May 28, 1980
ANALGESIA UNITS, OXYGEN & NITRATE DEVICE
K800801 · BSZ
Spica, Inc.
Anesthesiology · 48d
Cleared May 28, 1980
KANDI-NUCLEAR MED. DATA ACQU.&INFO.
K800835
Krupp International, Inc.
Radiology · 44d
Cleared May 28, 1980
ROYAL
K800866 · BZR
Trident Dental, Inc.
Anesthesiology · 42d
Cleared May 28, 1980
DOSE CALIBRATION REF. SOURCES
K800867
Amersham Corp.
Radiology · 41d
Cleared May 28, 1980
MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA
K800869 · CCK
Cavitron Corp.
Anesthesiology · 41d
Cleared May 28, 1980
RESTERILIZATION OF IMPLANTABLE ELECTRODE
K800891 · DTB
Telectronics, Inc.
Cardiovascular · 40d
Cleared May 28, 1980
COMPUTRIM 900
K800939 · ISD
Amf, Inc.
Physical Medicine · 36d
Cleared May 28, 1980
XYLOSE LYSINE DESOXYCHOLATE AGAR
K800978 · JSH
Quality Assurance Laboratory, Inc.
Microbiology · 35d
Cleared May 28, 1980
CHOCOLATE AGAR W/ENRICHMENTS
K800981 · JSG
Quality Assurance Laboratory, Inc.
Microbiology · 35d
Cleared May 28, 1980
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR
K800988 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 34d
Cleared May 28, 1980
ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.
K800998
General X-Ray, Inc.
Radiology · 33d
Cleared May 28, 1980
CAM-10 EXSUFFLATION BELT #11-001
K800999 · CBK
Lifecare Services, Inc.
Anesthesiology · 33d
Cleared May 28, 1980
LARGE SCREEN CRT DISPLAY #1311B
K801000 · DXJ
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared May 28, 1980
AMBULATORY MONITOR AM-1
K801001 · DSH
Burdick Corp.
Cardiovascular · 33d
Cleared May 28, 1980
OTICON EARETTE HEARING AID #E17 HC
K801002 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared May 28, 1980
OTICON EARETTE HEARING AID #E17CF
K801003 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared May 28, 1980
ASL CUSTOM IN-THE-EAR HEARING AID #L
K801023 · ESD
American Sound Labs
Ear, Nose, Throat · 27d
Cleared May 28, 1980
IL MODEL 773 FLUORESCENCE LIGHT SCATTER
K801026 · JJG
Instrumentation Laboratory CO
Chemistry · 27d
Cleared May 28, 1980
MDS IMAGER
K801027
Medtronic Vascular
Radiology · 27d
Cleared May 28, 1980
CLINICAL DATA SYSTEM (CAM) MODULE
K801029 · LEJ
Adac Laboratories
Radiology · 27d