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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69241–69264 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2003
AUTOMOVE, MODEL AM800
K032955 · IPF
Danmeter A/S
Physical Medicine · 84d
Cleared Dec 15, 2003
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · DKB
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · MNH
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Dec 15, 2003
ZILVER 518 BILIARY STENT
K033348 · FGE
Cook, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 15, 2003
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
K033604 · IYO
Pie Medical
Radiology · 28d
Cleared Dec 15, 2003
PACS SOFTWARE SOLUTION 2003
K033624 · LLZ
Canon USA, Inc.
Radiology · 27d
Cleared Dec 15, 2003
MODIFICATION TO COATEST FACTOR VIII
K033631 · GGP
Instrumentation Laboratory CO
Hematology · 26d
Cleared Dec 15, 2003
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY...
K033701 · MVN
Ciba Vision Corporation
Ophthalmic · 20d
Cleared Dec 15, 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 17d
Cleared Dec 15, 2003
TRIDENT RESECTION ABLATOR
K033748 · GEI
Linvatec Corp.
General & Plastic Surgery · 14d
Cleared Dec 12, 2003
MOTILITY VISUALIZATION SYSTEM
K031169 · FFX
Sierra Scientific Instruments, Inc.
Gastroenterology & Urology · 242d
Cleared Dec 12, 2003
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K031812 · DXC
Vascular Control Systems, Inc.
Radiology · 183d
Cleared Dec 12, 2003
VERTELINK KOBRA SPINAL FIXATION SYSTEM
K032102 · KWQ
Vertelink Corporation
Orthopedic · 157d
Cleared Dec 12, 2003
AMNIOLENS
K032104 · NQB
Bio-Tissue, Inc.
Ophthalmic · 157d
Cleared Dec 12, 2003
CLARITY PET
K032866 · KPS
Shared P.E.T. Imaging, LLC
Radiology · 88d
Cleared Dec 12, 2003
AIACT KIT
K032952 · JBP
Sienco, Inc.
Hematology · 81d
Cleared Dec 12, 2003
MISSION CONTROLS
K033063 · JJS
Diamond Diagnostics, Inc.
Chemistry · 74d
Cleared Dec 12, 2003
KACEY INSULIN SYRINGE
K033166 · FMF
Kacey, Inc.
General Hospital · 73d
Cleared Dec 12, 2003
TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
K033230 · MYU
Parallax Medical, Inc.
Neurology · 67d
Cleared Dec 12, 2003
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
K033234 · DHA
Diagnostic Products Corp.
Chemistry · 67d
Cleared Dec 12, 2003
SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS
K033298 · DQA
Masimo Corp.
Anesthesiology · 59d
Cleared Dec 12, 2003
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
K033299 · LAF
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Dec 12, 2003
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454
K033366 · DIF
Bio-Rad
Toxicology · 52d
Cleared Dec 12, 2003
LARYNGEAL AUGMENTATION IMPLANT
K033398 · MIX
Bioform, Inc.
Ear, Nose, Throat · 49d