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
167329–167352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1980
REAGENT FOR DETERM. CREATININE IN H/SERU
K800685 · CGX
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. DIRECT BILIRUBIN
K800686 · CIG
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. GLUCOSE IN H/SERUM
K800687 · CGA
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC
K800688 · CIT
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. INORGANIC/PHOSPHORUS
K800690 · CEO
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. LACTATE/DEHYDROGENAS
K800691 · CFJ
Diagnostic Solutions, Inc.
Chemistry · 63d
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