FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83833–83856 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2000
CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
K994427 · GEX
Cynosure, Inc.
General & Plastic Surgery · 19d
Cleared Jan 18, 2000
CYNOSURE PHOTOGENICA SPIR
K994437 · GEX
Cynosure, Inc.
General & Plastic Surgery · 19d
Cleared Jan 14, 2000
MICROSTREP PLUS PANEL, VANCOMYCIN
K983953 · JWY
Dade Microscan, Inc.
Microbiology · 435d
Cleared Jan 14, 2000
INFRARED EAR THERMOMETER, MODEL KI-8120
K984551 · FLL
K-Jump Health Co., Ltd.
General Hospital · 388d
Cleared Jan 14, 2000
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991916 · FIP
Virginia Water Systems, Inc.
Gastroenterology & Urology · 221d
Cleared Jan 14, 2000
PHARMASEED, MODEL BT-103-1
K992007 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 213d
Cleared Jan 14, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared Jan 14, 2000
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
K992749 · MSX
Spacelabs Medical, Inc.
Cardiovascular · 151d
Cleared Jan 14, 2000
IBC FLOGUARD, MODEL 6050
K992785 · MJJ
International Biophysics Corp.
Cardiovascular · 148d
Cleared Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO...
K992851 · JBP
Roche Diagnostics Corp.
Hematology · 143d
Cleared Jan 14, 2000
FORTOSS-CEMA
K993238 · LYC
Biocomposites, Ltd.
Dental · 109d
Cleared Jan 14, 2000
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST,...
K993519 · JOX
Cardiovascular Diagnostics, Inc.
Hematology · 88d
Cleared Jan 14, 2000
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
K993679 · JWY
Dade Microscan, Inc.
Microbiology · 74d
Cleared Jan 14, 2000
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993924 · CFN
Wako Chemicals USA, Inc.
Immunology · 57d
Cleared Jan 14, 2000
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
K993927 · CZP
Wako Chemicals USA, Inc.
Immunology · 57d
Cleared Jan 14, 2000
HARDYDISK AZTREONAM, 30MCG
K994063 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Jan 14, 2000
HARDY DISK AMPICILLIN/SULBACTAM
K994067 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Jan 14, 2000
HEMOSITE TEST SYSTEM
K994073 · KHG
Gds Technology, LLC
Hematology · 43d
Cleared Jan 14, 2000
ACCESS OSTASE QC
K994277 · JJX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jan 14, 2000
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
K994316 · LNH
Siemens Medical Corp.
Radiology · 23d
Cleared Jan 14, 2000
XE CHECK
K994388 · GLQ
Streck Laboratories, Inc.
Hematology · 17d
Cleared Jan 14, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309,...
K994439 · JHX
Beckman Coulter, Inc.
Chemistry · 22d
Cleared Jan 13, 2000
BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
K990987 · MAI
Arthrex, Inc.
Orthopedic · 295d
Cleared Jan 13, 2000
MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
K991862 · MNI
Micomed GmbH
Orthopedic · 226d