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
52321–52344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2009
UROVAL BRS SYSTEM, MODEL BRS01
K083679 · IKN
Uroval
Neurology · 274d
Cleared Sep 11, 2009
VF LIQUIGEL
K083783 · MIX
Coapt Systems, Inc.
Ear, Nose, Throat · 266d
Cleared Sep 11, 2009
IST SNORING APPLIANCE
K090911 · LQZ
Dental Crafters
Dental · 163d
Cleared Sep 11, 2009
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
K091171 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 142d
Cleared Sep 11, 2009
VALLEYLAB SUCTION COAGULATOR, MODEL E3305
K091223 · GEI
Covidien LP
General & Plastic Surgery · 137d
Cleared Sep 11, 2009
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K091321 · MQV
Bacterin International, Inc.
Orthopedic · 129d
Cleared Sep 11, 2009
ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM
K091508 · LPH
Zimmer, Inc.
Orthopedic · 112d
Cleared Sep 11, 2009
CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
K091799 · HTN
Zimmer, Inc.
Orthopedic · 86d
Cleared Sep 11, 2009
HEARTRAIL III GUIDING CATHETER
K092372 · DQO
Terumo Corp.
Cardiovascular · 37d
Cleared Sep 11, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
K092497 · OLO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Sep 11, 2009
TRU FLU, MODEL 751230
K092553 · PSZ
Meridian Bioscience, Inc.
Microbiology · 22d
Cleared Sep 11, 2009
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
K092612 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 16d
Cleared Sep 10, 2009
UNITY BETA PLLA SYSTEM
K090175 · HWC
Bonutti Research, Inc.
Orthopedic · 230d
Cleared Sep 10, 2009
OSTEOMED FOOT PLATING SYSTEM
K091614 · HRS
Osteomed LP
Orthopedic · 99d
Cleared Sep 10, 2009
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
K091808 · DXX
Hansen Medical, Inc.
Cardiovascular · 84d
Cleared Sep 10, 2009
COMFORT TWIN NASAL MASK
K091843 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 80d
Cleared Sep 10, 2009
BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205
K091852 · EIH
Refractron Technologies Corp.
Dental · 79d
Cleared Sep 10, 2009
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
K091943 · MKJ
Cardiac Science Corporation
Cardiovascular · 72d
Cleared Sep 10, 2009
ALCATEL-LUCENT TELEHEATH MANAGER
K092635 · DRG
Alcatel-Lucent Canada, Inc.
Cardiovascular · 14d
Cleared Sep 09, 2009
SPINAL FORAMINOSCOPE
K082841 · HRX
Blazejewski Medi-Tech GmbH
Orthopedic · 348d
Cleared Sep 09, 2009
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
K090104 · JJX
DiaSorin, Inc.
Chemistry · 237d
Cleared Sep 09, 2009
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
K091544 · CFJ
Alfa Wassermann, Inc.
Chemistry · 105d
Cleared Sep 09, 2009
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
K091937 · HIB
Obp Corporation
Obstetrics & Gynecology · 71d
Cleared Sep 09, 2009
NSM-S15 SYSTEM
K092237 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 48d