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
166657–166680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1980
TESTOSTERONE KIT
K801666 · CDZ
Immuchem Corp.
Chemistry · 37d
Cleared Aug 27, 1980
TSH RIASSAY
K801691 · JLW
Ria Diagnostics
Chemistry · 35d
Cleared Aug 27, 1980
SALMONELLA FLAGELLAR A ANTIGEN & B
K801693 · GNC
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Aug 27, 1980
FLOTATION PAD FOR OPERATING TABLE
K801694 · FMP
Action Products, Inc.
General Hospital · 35d
Cleared Aug 27, 1980
SUR-FIT SYSTEM PRE-OPERATION SET
K801702 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 34d
Cleared Aug 27, 1980
MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
K801757 · FES
Medical Measurements, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 27, 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762 · DSI
General Electric Co.
Cardiovascular · 30d
Cleared Aug 27, 1980
VIVALITH 5, - MDL-201A & TDL-201A
K801763 · DXY
Pacesetter Systems
Cardiovascular · 30d
Cleared Aug 27, 1980
MICROBIOLOGY CULTURE MEDIA, C.L.E.D.
K801817 · JSH
Radiation Technology, Inc.
Microbiology · 27d
Cleared Aug 27, 1980
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
K801828 · DTL
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Aug 27, 1980
MEDI-TRACE DISP. FLUSHING DEV./MONITOR
K801829 · KRA
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Aug 27, 1980
MODEL 9300 ELECTROCARDIOVALIDATOR
K801830 · DSF
Del Mar Avionics
Cardiovascular · 26d
Cleared Aug 27, 1980
MODEL 9200 VIS-U-SCAN
K801832 · DSH
Del Mar Avionics
Cardiovascular · 26d
Cleared Aug 27, 1980
GAS-CHROMATOGRAPHIC PACKING
K801833 · DJA
Supelco, Inc.
Toxicology · 26d
Cleared Aug 27, 1980
IVAC 260 SERIES VOLUME TRIC INFUSION CON
K801861 · LDR
Y
General Hospital · 22d
Cleared Aug 27, 1980
CAL-COUNT
K801868 · ISD
Bayshore Systems Corp.
Physical Medicine · 22d
Cleared Aug 27, 1980
PRIMARY SOLUTION ADMIN. SET-#86-01-0 260
K801871 · FPA
Y
General Hospital · 22d
Cleared Aug 27, 1980
MODEL 86-01-1 260 SOLUTION ADMIN. SET
K801872 · FPA
Y
General Hospital · 22d
Cleared Aug 27, 1980
MODEL 86-21-0 260 SECONDARY MEDICATION
K801873 · FPA
Y
General Hospital · 22d
Cleared Aug 27, 1980
MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD
K801874 · FPA
Y
General Hospital · 22d
Cleared Aug 27, 1980
RESPONDER II
K801894 · BZQ
Clinical Microsystems Intl.
Anesthesiology · 19d
Cleared Aug 27, 1980
SYRINGE INFUSION PUMP #2716
K801904 · FRN
Harvard Apparatus, Inc.
General Hospital · 16d
Cleared Aug 27, 1980
FONIX TYPE 5100 HEARING AID ANALYZER
K801905 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared Aug 27, 1980
DIOPTRON III AUTOREFRACTOR
K801906 · HKO
Coherent Medical Division
Ophthalmic · 16d