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
36217–36240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2014
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (...
K142391 · JFY
ACON Laboratories, Inc.
Chemistry · 117d
Cleared Dec 22, 2014
AnthroBridge-Screw 25,30,35,40,45,50mm
K142528 · HWC
Agent Medical, LLC
Orthopedic · 104d
Cleared Dec 22, 2014
Caspian OCT/MESA Mini/DENALI Mini Spinal System
K142558 · KWP
K2m
Orthopedic · 102d
Cleared Dec 22, 2014
The Lipogems System
K142682 · MUU
Lipogems International Spa
General & Plastic Surgery · 94d
Cleared Dec 22, 2014
Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142771 · LYZ
Xuanhua Metallurgical Industry Co., Ltd.
General Hospital · 88d
Cleared Dec 22, 2014
Zimmer Persona Personalized Knee System
K142787 · JWH
Zimmer, Inc.
Orthopedic · 87d
Cleared Dec 22, 2014
ANTHEM PS Total Knee System
K142807 · JWH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Dec 22, 2014
Carnation Ambulatory Monitor
K143067 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 59d
Cleared Dec 22, 2014
HEMASORBPLUS press Resorable Hemostatic Bone Putty
K143069 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 56d
Cleared Dec 22, 2014
AxSOS 3 Ti Locking Plate System
K143138 · HRS
Stryker Trauma AG
Orthopedic · 49d
Cleared Dec 22, 2014
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)
K143195 · MHX
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 46d
Cleared Dec 22, 2014
Passage Hemostasis Valve
K143429 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 21d
Cleared Dec 21, 2014
The Optilite IgG3 kit
K142735 · CFN
The Binding Site Group , Ltd.
Immunology · 89d
Cleared Dec 20, 2014
ABX MICROS ES 60 CT
K141161 · GKZ
HORIBA ABX SAS
Hematology · 229d
Cleared Dec 19, 2014
VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
K132407 · DSI
Lifewatch Technologies , Ltd.
Cardiovascular · 504d
Cleared Dec 19, 2014
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE...
K133800 · FRA
Hgi Industires
General Hospital · 371d
Cleared Dec 19, 2014
NORIS MEDICAL DENTAL IMPLANTS SYSTEM
K140440 · DZE
Noris Medical , Ltd.
Dental · 301d
Cleared Dec 19, 2014
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
K140554 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 290d
Cleared Dec 19, 2014
PLATINUMGMT IPL SYSTEM CLOUD
K140668 · ONF
Global Medical Technology S.L.
General & Plastic Surgery · 276d
Cleared Dec 19, 2014
AEROSURE MEDIC
K140772 · BWF
Actegy , Ltd.
Anesthesiology · 267d
Cleared Dec 19, 2014
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
K141693 · FRG
Advanced Sterilization Products
General Hospital · 178d
Cleared CT Dec 19, 2014
NXSTAGE SYSTEM ONE
K141752 · ODN
Nxstage Medical, Inc.
Gastroenterology & Urology · 172d
Cleared Dec 19, 2014
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K141926 · OMP
Medela AG
General & Plastic Surgery · 156d
Cleared Dec 19, 2014
FIRSTSTIC N INTRODUCER
K141969 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 151d