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
165937–165960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1980
NOBLE MEDEL ENT TREATMENT UNIT
K801738 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
NOBLE MODEL DOUBLESIDED TREATMENT UNIT
K801739 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
TREATMENT UNIT FOR DOCTOR'S ROUNDS
K801740 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
PRETTY MODEL ENT TREATMENT UNIT
K801741 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
NEW FINE MODEL ENT TREATMENT UNIT
K801742 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
TERUMO FETAL MONITOR # FHM-602
K801747 · HGM
Terumo Medical Corp.
Obstetrics & Gynecology · 16d
Cleared Aug 13, 1980
MMI/GAELTEC CATHETER TIP PRESSURE
K801755 · GWM
Medical Measurements, Inc.
Neurology · 16d
Cleared Aug 13, 1980
IONESCU-SHILEY PERICARDIAL PATCH
K801764 · DXZ
Shiley, Inc.
Cardiovascular · 16d
Cleared Aug 13, 1980
CATHETER IRRIGATION SYRINGES, #3100,3110
K801781 · KQT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 16d
Cleared Aug 13, 1980
GENERAL PURPOSE IRRIGATING/ASPIR SYR.
K801782 · KQT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 16d
Cleared Aug 13, 1980
CATHETER IRRIGATION TRAYS, #3300, 3310 &
K801783 · EYN
The Healthcare Group Laboratories, Inc.
General & Plastic Surgery · 16d
Cleared Aug 13, 1980
URINARY CATHETERS #3400,3410 &3420
K801784 · KOD
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 16d
Cleared Aug 13, 1980
ELASTIC ADHESIVE BANDAGES(STERILE)
K801794 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 15d
Cleared Aug 13, 1980
THE COMFORT LIFT
K801796 · FMR
Gettner Enterprises, Inc.
General Hospital · 15d
Cleared Aug 13, 1980
MAINFLOW BACTERIA FILTER
K801803 · CAH
Omnicon Medical Corp.
General Hospital · 15d
Cleared Aug 13, 1980
ANESTHESIA BACTERIA FILTER
K801804 · CAH
Omnicon Medical Corp.
General Hospital · 15d
Cleared Aug 13, 1980
ORTHODONTIC BRACKET/SPEED/HANSON SPEED
K801809 · EJF
Strite Industries , Ltd.
Dental · 14d
Cleared Aug 13, 1980
FLOW MED 150
K801821 · FPA
D.R.O. Medical, Inc.
General Hospital · 13d
Cleared Aug 13, 1980
TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA
K801847 · JSH
Radiation Technology, Inc.
Microbiology · 9d
Cleared Aug 13, 1980
PARALLEL-A-PREP
K801853 · EGI
C.D. Charles, Inc.
Dental · 9d
Cleared Aug 13, 1980
CYCLOPAC TENS
K801855 · GZT
Dow Corning Wright
Neurology · 9d
Cleared Aug 13, 1980
OXYMETER & TRANSOXODE
K801858 · KLH
Thoracel
Microbiology · 9d
Cleared Aug 12, 1980
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 109d
Cleared Aug 12, 1980
CLIRANS TE10 HOLLOW FIBER DIALYZER
K801192 · FJI
Terumo America, Inc.
Gastroenterology & Urology · 85d