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

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175,820 results
35593–35616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2015
O-TWO E700,O-TWO E600,O-TWO E500
K141595 · BTL
O-Two Medical Technologies, Inc.
Anesthesiology · 276d
Cleared Mar 16, 2015
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K141929 · NDC
Roche Diagnostics Corporation
General Hospital · 243d
Cleared Mar 16, 2015
Sleepware G3
K142988 · OLZ
Respironics, Inc.
Neurology · 151d
Cleared Mar 16, 2015
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
K150030 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 67d
Cleared Mar 16, 2015
InTone
K150180 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 48d
Cleared Mar 16, 2015
NovaGold High Performance Guidewire
K150225 · OCY
Neometrics, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 16, 2015
Nautilus Spinal System
K150390 · NKB
Life Spine, Inc.
Orthopedic · 26d
Cleared Mar 13, 2015
HARMONY LITE
K141237 · ONF
Alma, Inc.
General & Plastic Surgery · 304d
Cleared Mar 13, 2015
NuVasive CoRoent System
K141665 · MAX
Nuvasive, Inc.
Orthopedic · 263d
Cleared CT Mar 13, 2015
HOME ACCESS AIC TEST
K141944 · LCP
Home Access Health Corp.
Chemistry · 239d
Cleared Mar 13, 2015
Dental Unit
K142206 · EIA
Zhuhai Siger Medical Equipment Co., Ltd.
Dental · 214d
Cleared Mar 13, 2015
EVA,anterior machine, EVA, combined machine, EVA combined machine with...
K142877 · HQC
Dutch Ophthalmic Research Center...
Ophthalmic · 163d
Cleared Mar 13, 2015
Liquichek Maternal Serum II Control
K143379 · JJY
Bio-Rad Laboratories
Chemistry · 108d
Cleared Mar 13, 2015
Progrip Laparoscopic Self-Fixating Mesh
K143386 · FTL
Sofradim Production
General & Plastic Surgery · 107d
Cleared Mar 12, 2015
NEURO-AUDIO
K141524 · EWO
Teleemg, LLC USA
Ear, Nose, Throat · 276d
Cleared Mar 12, 2015
CardiacLinx
K142352 · DSI
Ross Medical Technology, Inc.
Cardiovascular · 202d
Cleared Mar 12, 2015
Biomet Spine Fusion System
K142634 · MAX
Biomet Spine, LLC
Orthopedic · 176d
Cleared Mar 12, 2015
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
K142766 · LPL
INTEROJO, Inc.
Ophthalmic · 168d
Cleared Mar 12, 2015
Triton Canister System
K142801 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 164d
Cleared Mar 12, 2015
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners,...
K142873 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 162d
Cleared Mar 12, 2015
Lapro-Clip Auto Suture Reusable Long Clip Applier
K143598 · FZP
Covidien, LLC
General & Plastic Surgery · 84d
Cleared Mar 12, 2015
Bissinger Monopolar Forceps and Cables
K143662 · GEI
Medagent, Inc.
General & Plastic Surgery · 79d
Cleared Mar 11, 2015
STERILIZATION POUCH/ROLL MADE WITH TYVEK
K133838 · FRG
Sigma Medical Supplies Corp.
General Hospital · 448d
Cleared Mar 11, 2015
KONUS DENTAL IMPLANT SYSTEM
K141159 · DZE
Argon Med. Productions Vertriebs...
Dental · 310d