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

Filters: Cleared only ×
176,076 results
56545–56568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2008
URIC ACID (AOX), SCAL, NORTROL, ABTROL
K073612 · JIX
Thermofisher Scientific OY
Chemistry · 154d
Cleared May 23, 2008
ARCOFIX
K080020 · KWQ
Synthes Spine Co.Lp
Orthopedic · 141d
Cleared May 23, 2008
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
K080255 · DQA
Nonin Medical, Inc.
Anesthesiology · 113d
Cleared May 23, 2008
SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
K080321 · MNR
Snap Laboratories, LLC
Anesthesiology · 107d
Cleared May 23, 2008
WATCH-PAT MODEL 100S-2
K080427 · MNR
Itamar Medical
Anesthesiology · 98d
Cleared May 23, 2008
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
K080522 · HRS
Synthes (Usa)
Orthopedic · 87d
Cleared May 23, 2008
ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
K080547 · HAW
Aesculap Implant System, Inc.
Neurology · 85d
Cleared May 23, 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
K080618 · LCP
Jas Diagnostics, Inc.
Chemistry · 79d
Cleared May 23, 2008
CLEANSE.FRESHEN.GO
K080631 · EFT
Oral Health Technologies, LLC
Dental · 79d
Cleared May 23, 2008
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
K080842 · MBH
Omni Life Science, Inc.
Orthopedic · 59d
Cleared May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
K080869 · LGD
Beckman Coulter, Inc.
Microbiology · 53d
Cleared May 23, 2008
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
K080937 · LZA
Gx Corporation Sdn Bhd
General Hospital · 51d
Cleared May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF...
K081074 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared May 23, 2008
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
K081154 · IYO
B-K Medical Aps
Radiology · 30d
Cleared May 23, 2008
AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR
K081169 · GCJ
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 29d
Cleared May 23, 2008
CONCAVE RN HEALING CAP
K081186 · NHA
Institut Straumann AG
Dental · 25d
Cleared May 22, 2008
SPACER-G TEMPORARY HIP PROSTHESIS
K062273 · KWL
Tecres S.P.A.
Orthopedic · 654d
Cleared May 22, 2008
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121,...
K062274 · JWH
Tecres S.P.A.
Orthopedic · 654d
Cleared May 22, 2008
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
K073684 · KMJ
Sheffield Industries, Div. of Faria ,...
General Hospital · 146d
Cleared May 22, 2008
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
K080159 · JZO
Kronus Market Development Associates,...
Immunology · 120d
Cleared May 22, 2008
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
K080257 · GCJ
Medtronic Xomed, Inc.
General & Plastic Surgery · 112d
Cleared May 22, 2008
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
K081217 · DHB
Hycor Biomedical, Inc.
Immunology · 22d
Cleared May 22, 2008
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
K081291 · DYH
Dentsply Interntional
Dental · 15d