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
73753–73776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2002
CYNOSURE PHOTOGENICA SV
K021444 · GEX
Cynosure, Inc.
General & Plastic Surgery · 198d
Cleared Nov 20, 2002
QUICKLAB RSV
K021789 · GQG
Integrated Biotechnology Corp.
Microbiology · 173d
Cleared Nov 20, 2002
OTI UNICONDULAR INTERPOSITIONAL SPACER
K022779 · HSH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Nov 20, 2002
IMAGECHECKER-CT WORKSTATION
K023003 · LLZ
R2 Technology, Inc.
Radiology · 72d
Cleared Nov 20, 2002
SONOREAL 3D
K023473 · IYO
Bio Medi Com
Radiology · 35d
Cleared Nov 20, 2002
6 CHANNEL BODY COIL
K023571 · MOS
Siemens Medical Systems, Inc.
Radiology · 27d
Cleared Nov 20, 2002
ASCENSIA DEX 2 DIABETES CARE SYSTEM
K023584 · NBW
Bayer Corp.
Chemistry · 26d
Cleared Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · NFJ
Nidek, Inc.
Ophthalmic · 377d
Cleared Nov 19, 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 252d
Cleared Nov 19, 2002
ORIA SPINAL CLIP SYSTEM
K021679 · KWP
Ortho Tec, LLC
Orthopedic · 182d
Cleared Nov 19, 2002
ASSUFIL
K021767 · GAM
Assut Europe S.P.A.
General & Plastic Surgery · 174d
Cleared Nov 19, 2002
INSOUND XT SERIES HEARING AID
K021867 · ESD
Insound Medical, Inc.
Ear, Nose, Throat · 166d
Cleared Nov 19, 2002
HIP MODULE FOR THE STEALTHSTATION SYSTEM
K021980 · HAW
Medtronic Surgical Navigation...
Neurology · 155d
Cleared Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
K022516 · NBC
Roche Diagnostics Corp.
Chemistry · 112d
Cleared Nov 19, 2002
PHFW-10
K022539 · ITI
Pihsiang Machinery Mfg. Co., Ltd.
Physical Medicine · 110d
Cleared Nov 19, 2002
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · LYL
Ciba Vision Corporation
Ophthalmic · 98d
Cleared Nov 19, 2002
MANUAL TOUCHE SYSTEM
K022777 · GAQ
Onux Medical, Inc.
General & Plastic Surgery · 90d
Cleared Nov 19, 2002
TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
K022783 · DXN
Tensys Medical, Inc.
Cardiovascular · 89d
Cleared Nov 19, 2002
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES...
K022798 · KWQ
Corin USA
Orthopedic · 88d
Cleared Nov 19, 2002
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
K022841 · GZJ
Biomedical Life Systems, Inc.
Neurology · 84d
Cleared Nov 19, 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K022925 · GZJ
Biomedical Life Systems, Inc.
Neurology · 76d
Cleared Nov 19, 2002
THE BIOPLATE BATTERY POWERED DRILL
K022986 · HBC
Bioplate, Inc.
Neurology · 71d
Cleared Nov 19, 2002
MONARC SLING SYSTEM
K023516 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 29d