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
79177–79200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2001
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
K011052 · JMM
Ostex Intl., Inc.
Chemistry · 115d
Cleared Jul 30, 2001
RADS
K011054 · DIO
Chason Healthcare, LLC
Toxicology · 115d
Cleared Jul 30, 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · DJG
ACON Laboratories, Inc.
Toxicology · 88d
Cleared Jul 30, 2001
MITYVAC
K011532 · HDB
Prism Enterprises, Inc.
Obstetrics & Gynecology · 73d
Cleared Jul 30, 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
K011662 · DDG
The Binding Site, Ltd.
Immunology · 62d
Cleared Jul 30, 2001
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
K011663 · DEM
The Binding Site, Ltd.
Immunology · 62d
Cleared Jul 27, 2001
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL...
K002336 · IPF
Apex Medical Corp.
Physical Medicine · 360d
Cleared Jul 27, 2001
WELL-TENS
K002874 · GZJ
Well-Life Consultant
Neurology · 316d
Cleared Jul 27, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159 · LTT
Dade Microscan, Inc.
Microbiology · 191d
Cleared Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
K011140 · LLL
Inova Diagnostics, Inc.
Immunology · 105d
Cleared Jul 27, 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
HYDRO2, HS-75
K011914 · HQD
Innovision, Inc.
Ophthalmic · 38d
Cleared Jul 27, 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
K012028 · LFL
Misonix, Inc.
General & Plastic Surgery · 29d
Cleared Jul 27, 2001
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
K012035 · DXN
Braun GmbH
Cardiovascular · 28d
Cleared Jul 27, 2001
MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
K012060 · ELC
Hu-Friedy Mfg. Co., Inc.
Dental · 25d
Cleared Jul 27, 2001
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
K990667 · NEI
KLS-Martin L.P.
Dental · 878d
Cleared Jul 26, 2001
GSI AUDERA
K011135 · EWO
Nicolet Biomedical
Ear, Nose, Throat · 104d
Cleared Jul 26, 2001
RF-IVD WIRELESS DOSIMETER-MODEL 1133
K011332 · IYE
Sun Nuclear Corp.
Radiology · 85d
Cleared Jul 26, 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jul 26, 2001
VIKING OPTIMA GUIDING CATHETER
K012002 · DQY
Guidant Corp.
Cardiovascular · 29d
Cleared Jul 26, 2001
MODIFICATION TO THERMAL ANGEL
K012031 · BSB
Estill Medical Technologies, Inc.
Hematology · 28d
Cleared Jul 26, 2001
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND...
K012095 · JWH
Implex Corp.
Orthopedic · 21d
Cleared Jul 26, 2001
TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC...
K012191 · IYN
Teratech Corp.
Radiology · 13d