Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
55225–55248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2008
QUANTA LITE OMP PLUS ELISA
K081248 · OKM
Inova Diagnostics, Inc.
Immunology · 178d
Cleared Oct 27, 2008
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
K081733 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 130d
Cleared Oct 27, 2008
MPOWRX SNORING SOLUTION
K081965 · LRK
Mpowrx Health and Wellness Products,...
Dental · 109d
Cleared Oct 27, 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL...
K082164 · CAZ
PAJUNK GmbH Medizintechnologie
Anesthesiology · 88d
Cleared Oct 27, 2008
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
K082464 · KNS
Medtronic, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 27, 2008
COOK WIRE GUIDES
K082536 · OCY
Cook Urological, Inc.
Gastroenterology & Urology · 55d
Cleared Oct 27, 2008
UC-CARE POSITIONING SYSTEM
K082919 · EZL
Uc-Care Medical Systems, Ltd.
Gastroenterology & Urology · 27d
Cleared Oct 27, 2008
KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
K083043 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 13d
Cleared Oct 24, 2008
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
K081413 · HIS
Dailian Latex Company, Ltd.
Obstetrics & Gynecology · 157d
Cleared Oct 24, 2008
SENSITITRE VIZION
K081520 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Oct 24, 2008
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
K081587 · MNW
Krell Precision (Yang Zhou) Co., Ltd.
Gastroenterology & Urology · 141d
Cleared Oct 24, 2008
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
K081732 · DAP
Siemens Healthcare Diagnostics
Hematology · 127d
Cleared Oct 24, 2008
TEMPORARY TOOTH REPLACEMENT
K081900 · DZE
Ormco Corp.
Dental · 113d
Cleared Oct 24, 2008
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
K082120 · KWS
Tornier
Orthopedic · 88d
Cleared Oct 24, 2008
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980
K082263 · GEX
Biolitec, Inc.
General & Plastic Surgery · 77d
Cleared Oct 24, 2008
EASY GLAZE
K082285 · EBD
Voco GmbH
Dental · 74d
Cleared Oct 24, 2008
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082597 · LYZ
Tangshan Linyuan Plastic Products...
General Hospital · 46d
Cleared Oct 24, 2008
VANGUARD CR STEM HOUSINGS
K082826 · JWH
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Oct 24, 2008
DISTAL RADIO-ULNAR JOINT IMPLANT
K082839 · KXE
Aptis Medical, LLC
Orthopedic · 28d
Cleared Oct 24, 2008
MULLINS-X, MODEL 250X
K082868 · DQY
NuMED, Inc.
Cardiovascular · 25d
Cleared Oct 24, 2008
PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C,...
K082923 · CAC
Life-Tech, Inc.
Anesthesiology · 23d
Cleared Oct 24, 2008
LEVO C3
K083017 · IPL
Levo AG
Physical Medicine · 15d
Cleared Oct 23, 2008
ABC SYRINGE INFUSION PUMP, MODEL 4100
K072603 · FRN
Elixir Corporation
General Hospital · 405d
Cleared Oct 23, 2008
BINAXNOW G6PD TEST
K080003 · JBF
Binax, Inc.
Hematology · 295d