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
170137–170160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1979
H-H FIXATION AND JOINING CONNECTORS
K790849 · JXG
Holter-Hausner Intl.
Neurology · 8d
Cleared May 08, 1979
PROTHESIS, RETAINED GEOMETRIC KNEE
K790219 · JWH
Zimmer, Inc.
Orthopedic · 98d
Cleared May 08, 1979
28 UNIPOLAR AND BIPOLAR PULSE GENERATORS
K790452 · DXY
Edwards Pacemaker Systems
Cardiovascular · 64d
Cleared May 08, 1979
AUTOMATIC ELECTRONIC SPHYMOMONOMETER
K790537 · DXN
Healthcare Enterprises, Inc.
Cardiovascular · 49d
Cleared May 08, 1979
PULSE GENERATOR MODEL 61 AND 128
K790562 · DXY
Ela Medical, Inc.
Cardiovascular · 50d
Cleared May 08, 1979
KIMLON UNIVERSAL DRAPE
K790636 · KKX
Kimberly-Clark Corp.
General Hospital · 36d
Cleared May 08, 1979
LEY ELECTRO-SURGICAL UNITS
K790642 · GEI
Merced Medical, Inc.
General & Plastic Surgery · 39d
Cleared May 08, 1979
OXYGEN HUMIDIFIER KIT
K790731 · BTT
Abbott Laboratories
Anesthesiology · 22d
Cleared May 08, 1979
HEMOCLEAR U-NEPHROS 1.0 DIALYZER
K790758 · FJG
Medical, Inc.
Gastroenterology & Urology · 21d
Cleared May 07, 1979
SLENDERTONE
K790120 · IPF
Bloomex International, Inc.
Physical Medicine · 104d
Cleared May 07, 1979
PAP RIA KIT
K790317 · JFH
Yang Laboratories, Inc.
Chemistry · 81d
Cleared May 07, 1979
CENTRIA SYSTEM
K790550 · JJG
Union Carbide Corp.
Chemistry · 48d
Cleared May 07, 1979
CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC
K790556 · CHH
Calbiochem-Behring Corp.
Chemistry · 49d
Cleared May 07, 1979
EO EVACUATING SYSTEM I
K790677 · FLI
Castle Co.
General Hospital · 28d
Cleared May 07, 1979
KOORDINAT 3D
K790783 · KXJ
Siemens Corp.
Radiology · 14d
Cleared May 07, 1979
RIA KIT, QUANTITATION OF PROSTATIC ACID
K790817 · JFH
New England Nuclear
Chemistry · 10d
Cleared May 07, 1979
MOIRE CONTOURGRAPH, MODELS MS-1, SS-1
K790861
Otal Precision Co. , Ltd.
Physical Medicine
Cleared May 04, 1979
ELDONCARD
K790282 · KSZ
Nordisk Infuser System
Hematology · 80d
Cleared May 04, 1979
TREATED BARRIER INCISE DRAPE
K790431 · KKX
Surgikos, Inc.
General Hospital · 63d
Cleared May 04, 1979
CUSTOM TUBING SETS
K790604 · FPA
Norton Performance Plastics Corp.
General Hospital · 46d
Cleared May 04, 1979
OMNIMEDICAL AUTOMATIC 1001
K790673 · IZL
Omnimedical
Radiology · 25d
Cleared May 04, 1979
MEVATRON 74
K790747 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 18d
Cleared May 04, 1979
VS, ANESTHESIA VENTILATOR
K790809 · CBK
Airco/Ohio Medical Products
Anesthesiology · 8d
Cleared May 04, 1979
NON-REBREATHING T PIECE
K790820 · CBP
Dhd Medical Products Div. Diemolding...
Anesthesiology · 3d