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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118993–119016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1991
PRC AUTOPSY DEVICE
K913536 · KKX
Pennstate
General Hospital · 105d
Cleared Nov 22, 1991
TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS
K913633 · LZO
Intermedics Orthopedics
Orthopedic · 99d
Cleared Nov 22, 1991
SMITH AND DAVIS PRESSURE THERAPY SYSTEM
K913654 · INX
Smith & Davis Mfg. Co.
Physical Medicine · 98d
Cleared Nov 22, 1991
RECORD AND VERIFY MEVATRON ADAPTER
K913674 · IYE
Computerized Medical Systems, Inc.
Radiology · 95d
Cleared Nov 22, 1991
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
K913812 · JDI
Osteonics Corp.
Orthopedic · 88d
Cleared Nov 22, 1991
OLYMPUS FLEXIBLE TIP THORACOSCOPE
K913829 · EWY
Olympus Corp.
Ear, Nose, Throat · 88d
Cleared Nov 22, 1991
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
K913830 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Nov 22, 1991
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K913921 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Nov 22, 1991
PERCUTANEOUS DILATOR WITH SHEATH
K913932 · FGE
Interventional Therapeutics Corp.
Gastroenterology & Urology · 80d
Cleared Nov 22, 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K913996 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Nov 22, 1991
TARGET THERAPEUTICS RADIOPAQUE STYLET
K914001 · DRB
Target Therapeutics
Cardiovascular · 77d
Cleared Nov 22, 1991
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
K914018 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Nov 22, 1991
TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
K914025 · CIT
Technicon Instruments Corp.
Chemistry · 74d
Cleared Nov 22, 1991
CIRCON ACMI CAT.# LAP 9900
K914101 · HIF
Circon Video
Obstetrics & Gynecology · 71d
Cleared Nov 22, 1991
INCUBATOR 8000 SC
K914134 · FMZ
National Draeger, Inc.
General Hospital · 115d
Cleared Nov 22, 1991
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
K914170 · DIF
Bio-Rad
Toxicology · 66d
Cleared Nov 22, 1991
CATH CONTROL
K914211 · KNY
Highpoint Medical Corp.
Gastroenterology & Urology · 64d
Cleared Nov 22, 1991
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
K914225 · JZG
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 63d
Cleared Nov 22, 1991
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
K914263 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 60d
Cleared Nov 22, 1991
I-125 SEEDS IN CARRIER, CODE: 6720
K914268 · KXK
Medi-Physics Inc. Dba Nycomed...
Radiology · 60d
Cleared Nov 22, 1991
I-125 SEEDS, CODE: 6711
K914281 · KXK
Medi-Physics Inc. Dba Nycomed...
Radiology · 59d
Cleared Nov 22, 1991
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS
K914312 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 57d
Cleared Nov 22, 1991
ICON COMPUTER SYSTEM
K914350 · JWM
Siemens Gammasonics, Inc.
Radiology · 56d
Cleared Nov 22, 1991
CORDIS OBTURATOR
K914352 · DYB
Cordis Corp.
Cardiovascular · 53d