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
156145–156168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1983
CHOLESTEROL-ENZYMATIC REAGENT SET
K831863 · CHH
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 22, 1983
URIC-ACID TEST ENZYMATIC COLORIMETRIC
K831864 · KNK
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 19, 1983
VASCULAR GRAFT PROSTHESIS EXPANDED MICR
K830543 · DSY
Impra, Inc.
Cardiovascular · 147d
Cleared Jul 19, 1983
THE BLOOM STETHOSCOPE
K830796 · LDE
Stethophonics, Inc.
Cardiovascular · 127d
Cleared Jul 19, 1983
COLOSTOMY BAG
K830841 · EXB
C & D Colostomy Pad Corp.
Gastroenterology & Urology · 124d
Cleared Jul 19, 1983
KNEE PROSTHESIS-TIBIAL COMPONENT
K830927 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 118d
Cleared Jul 19, 1983
PECGASYS REMOTE TRANSMISSION UNIT
K831092 · DXH
Datamedix
Cardiovascular · 106d
Cleared Jul 19, 1983
DRIONIC
K831320 · EGJ
General Medical Co.
Physical Medicine · 88d
Cleared Jul 19, 1983
NEONATAL NASOGASTRIC FEEDING TUBE-
K831328 · KNT
Corpak Medsystems
Gastroenterology & Urology · 85d
Cleared Jul 19, 1983
COMPRESSAR DISPOSABLE DISC
K831337 · DQO
Instromedix, Inc.
Cardiovascular · 85d
Cleared Jul 19, 1983
FREEDOM 19 RECREATIONAL WHEELCHAIR
K831510 · IQC
Carbonite Corp.
Physical Medicine · 68d
Cleared Jul 19, 1983
BETA SCAN NORMAL CONTROL SOLUTION
K831523 · JJX
Orange Medical Instruments, Inc.
Chemistry · 68d
Cleared Jul 19, 1983
VAPOR-PHASE HUMIDIFIER SYSTEM
K831556 · BTT
Cygnus Research Corp.
Anesthesiology · 64d
Cleared Jul 19, 1983
MICRO-THIN SURGICAL GLOVE
K831565 · KGO
Ansell, Inc.
General Hospital · 64d
Cleared Jul 19, 1983
GP-303
K831583 · DXN
Hirata Sangyo Co. USA, Inc.
Cardiovascular · 63d
Cleared Jul 19, 1983
HCG ACCU-STICK
K831604 · JHI
Btc Diagnostics, Inc.
Chemistry · 62d
Cleared Jul 19, 1983
GLUCOSE REAGENT B6360-11
K831634 · CGA
American Scientific Products
Chemistry · 60d
Cleared Jul 19, 1983
DISPOSABLE HEMOSTAT (STRAIGHT&CURVED
K831662 · KDC
Medcare Products
General & Plastic Surgery · 57d
Cleared Jul 19, 1983
RENAK
K831694 · CIB
Hoffmann-La Roche, Inc.
Chemistry · 56d
Cleared Jul 19, 1983
MULTICHEM ENZYMATIC CHOLESTEROL SYS
K831700 · CHH
Simmler, Inc.
Chemistry · 56d
Cleared Jul 19, 1983
TRICYCLIC ANTIDEPRESSNATS VI
K831737 · DIF
Utak Laboratories, Inc.
Toxicology · 49d
Cleared Jul 19, 1983
TRANSCUTANEOUS OXYGEN MONITOR OPTION
K831744 · KLK
Ge Medical Systems Information...
Anesthesiology · 49d
Cleared Jul 19, 1983
FLOW-CALIBRATION MODULE
K831758 · BXW
The Perkin-Elmer Corp.
Anesthesiology · 48d
Cleared Jul 19, 1983
HEMOSTATS
K831797 · HRQ
I M, Inc.
General & Plastic Surgery · 46d