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
83329–83352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 13, 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · DXC
Aesculap, Inc.
Cardiovascular · 209d
Cleared Jan 13, 2000
ITP, MODEL 1.0
K992434 · MUJ
Nucletron Corp.
Radiology · 176d
Cleared Jan 13, 2000
VENAFLOW SYSTEM, MODEL 30A
K992454 · JOW
Aircast, Inc.
Cardiovascular · 174d
Cleared Jan 13, 2000
PE 501 PC-ECG MONITOR
K992584 · MWJ
Nhe Corp.
Cardiovascular · 164d
Cleared Jan 13, 2000
NIPRO LUER ADAPTOR
K992729 · FMI
Nipro Medical Corp.
General Hospital · 153d
Cleared Jan 13, 2000
A-2000 BATHING SYSTEMS
K992779 · ILJ
Medi-Man Rehabilitation Products, Inc.
Physical Medicine · 148d
Cleared Jan 13, 2000
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
K993377 · NAQ
Polymer Technology Systems, Inc.
Chemistry · 107d
Cleared Jan 13, 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531 · DSI
Datascope Corp.
Cardiovascular · 87d
Cleared Jan 13, 2000
AVIVA SYSTEM, MODEL SL1010
K993550 · DRG
American Telecare, Inc.
Cardiovascular · 85d