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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
50857–50880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2010
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
K100080 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 66d
Cleared Mar 19, 2010
ESTHETICA
K100083 · EBF
Kerr Corporation
Dental · 66d
Cleared Mar 19, 2010
SLIT LAMP BO 900, BQ 900, BP900
K100202 · HJO
Haag-Streit AG
Ophthalmic · 53d
Cleared Mar 19, 2010
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
K100293 · JIT
Siemens Heatlhcare Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 19, 2010
OPUS SPEEDSCREW SYSTEM
K100457 · HWC
Arthrocare Corp.
Orthopedic · 30d
Cleared Mar 18, 2010
ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW
K091631 · LLZ
Aspyra, Inc.
Radiology · 288d
Cleared Mar 18, 2010
TINA-QUANT CERULOPLASMIN
K091741 · CHN
Roche Diagnostics
Immunology · 275d
Cleared Mar 18, 2010
BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED...
K092149 · GEI
Bovie Medical
General & Plastic Surgery · 245d
Cleared Mar 18, 2010
SOFTVIEW, MODEL 2.01
K092363 · LLZ
Riverain Medical Group
Radiology · 225d
Cleared Mar 18, 2010
BIO-OSS COLLAGEN
K092428 · NPM
Ed. Geistlich Soehne AG Fuer...
Dental · 223d
Cleared Mar 18, 2010
DIGITAL RETINAL CAMERA CX-1
K092565 · HKI
Canon Components, Inc.
Ophthalmic · 210d
Cleared Mar 18, 2010
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
K092699 · GWL
Neurotronics, Inc.
Neurology · 197d
Cleared Mar 18, 2010
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
K092944 · FRC
Dana Products, Inc.
General Hospital · 175d
Cleared Mar 18, 2010
IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500,...
K093419 · NDN
Stryker Instruments, Instruments Div.
Orthopedic · 136d
Cleared Mar 18, 2010
COAGUCHEK XS PRO SYSTEM
K093460 · GJS
Roche Diagnostics
Hematology · 132d
Cleared Mar 18, 2010
STORM-BASE 2.0
K093603 · LLZ
KARL STORZ Endoscopy-America, Inc.
Radiology · 118d
Cleared Mar 18, 2010
SEC IBF CAGE
K093669 · MAX
Innvotec Surgical, Inc.
Orthopedic · 111d
Cleared Mar 18, 2010
MODIFICATION TO: OASYS SYSTEM
K093670 · MNH
Stryker Spine
Orthopedic · 111d
Cleared Mar 18, 2010
LED LIGHT SOURCE
K093792 · FCW
Sunoptic Technologies, LLC
Gastroenterology & Urology · 98d
Cleared Mar 18, 2010
ARTHREX TIBIAL GRAFTBOLT
K093912 · MBI
Arthrex, Inc.
Orthopedic · 86d
Cleared Mar 18, 2010
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS...
K093957 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 85d
Cleared Mar 18, 2010
CP-FIBER (ORTHOFIBER)
K094028 · GAT
Cp Medical
General & Plastic Surgery · 78d
Cleared Mar 18, 2010
WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)
K100226 · FLL
Rio Flexon Technology Co., Ltd.
General Hospital · 52d
Cleared Mar 17, 2010
WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
K092558 · DXN
Harvard Medical Devices , Ltd.
Cardiovascular · 209d