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
169297–169320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 03, 1979
H-D-EL
K790372 · LBR
General Diagnostics
Chemistry · 69d
Cleared May 03, 1979
PROGESTERONE
K790440 · JLS
Serono Laboratories, Inc.
Chemistry · 57d
Cleared May 03, 1979
T-3 UPTAKE (MAA) KIT
K790461 · KHQ
Amersham Corp.
Chemistry · 59d
Cleared May 03, 1979
COULTER ACCU-ZYME II GOT REAGENT
K790483 · CIT
Coulter Electronics, Inc.
Chemistry · 55d
Cleared May 03, 1979
AMYLOCHROME STAT SEPARATOR, TEST
K790485 · JKA
Hoffmann-La Roche, Inc.
Chemistry · 52d
Cleared May 03, 1979
THYROXINE RIA KIT
K790495 · CDX
Technia Diagnostics , Ltd.
Chemistry · 51d