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
79225–79248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2001
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
K011438 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 74d
Cleared Jul 23, 2001
TOOTH SHADE RESIN MATERIAL
K011453 · EBF
Rite-Dent Manufacturing Corp.
Dental · 73d
Cleared Jul 23, 2001
RESTORE-X
K011520 · EMA
First Scientific Limited
Dental · 67d
Cleared Jul 23, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · KWP
Endius, Inc.
Orthopedic · 41d
Cleared Jul 23, 2001
FRESENIUS C.A.T.S
K012178 · CAC
Fresenius Hemotechnology, Inc.
Anesthesiology · 11d
Cleared Jul 23, 2001
ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520,...
K012207 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 7d
Cleared Jul 22, 2001
HYSTEROSCOPES
K003802 · HIH
Global Endoscopy, Inc.
Obstetrics & Gynecology · 226d
Cleared Jul 22, 2001
GYNECOLOGICAL LAPAROSCOPES
K003805 · HET
Global Endoscopy, Inc.
Obstetrics & Gynecology · 226d
Cleared Jul 20, 2001
ARTHROSCOPES
K003831 · HRX
Global Endoscopy, Inc.
Orthopedic · 221d
Cleared Jul 20, 2001
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT,...
K003851 · DCK
Biocheck, Inc.
Chemistry · 220d
Cleared Jul 20, 2001
MACROPORE OS SPINAL SYSTEM
K010911 · KWQ
Macropore Biosurgery, Inc.
Orthopedic · 116d
Cleared Jul 20, 2001
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K011118 · HRS
Osteomedics
Orthopedic · 99d
Cleared Jul 20, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
K011235 · JPA
Dade Behring, Inc.
Hematology · 88d
Cleared Jul 20, 2001
FLAVORED MALE LATEX CONDOM
K011253 · HIS
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 87d
Cleared Jul 20, 2001
NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001
K011310 · DXN
Nien Made Electrnics Corp.
Cardiovascular · 81d
Cleared Jul 20, 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · JDW
Stryker Endoscopy
Orthopedic · 80d
Cleared Jul 20, 2001
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
K011345 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 79d
Cleared Jul 20, 2001
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE...
K011352 · DXN
Rossmax International , Ltd.
Cardiovascular · 78d
Cleared Jul 20, 2001
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
K011539 · DXN
Rossmax International , Ltd.
Cardiovascular · 63d
Cleared Jul 20, 2001
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · CJE
Jas Diagnostics, Inc.
Chemistry · 57d
Cleared Jul 20, 2001
FADASIS MEDICAL FM-1 NO BLENDER
K011874 · MRO
Fadasis Medical, Inc.
Anesthesiology · 35d
Cleared Jul 20, 2001
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
K012016 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Jul 20, 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019 · JDI
Biomet, Inc.
Orthopedic · 22d
Cleared Jul 20, 2001
MODIFICATION TO XIA SPINE SYSTEM
K012027 · MNH
Howmedica Osteonics
Orthopedic · 22d