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
156985–157008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1983
SURGICAL FACE MASK-DISPOSABLE
K832194 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 18d
Cleared Jul 26, 1983
GAUZE CONVERSION CLASS II STERILE
K832213 · EFQ
Winn Hirsch & Assoc.
General & Plastic Surgery · 14d
Cleared Jul 26, 1983
GAUZE CONVERSION CLASS I-NON-STERILE
K832214 · EFQ
Winn Hirsch & Assoc.
General & Plastic Surgery · 14d
Cleared Jul 26, 1983
I.V. BAG ADDISEAL
K832247 · KPE
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 15d
Cleared Jul 26, 1983
BAXA ADDISEAL
K832254 · KPE
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 15d
Cleared Jul 22, 1983
TRIGLYCERIDES REAGENT SET
K831858 · CDT
Stanbio Laboratory
Chemistry · 42d
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