FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
115177–115200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1993
DRITRAINER
K930005 · KPN
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 58d
Cleared Mar 03, 1993
TRACHEAL TUBE FIXATION DEVICE
K930179 · BTR
Garrett Medical Products
Anesthesiology · 48d
Cleared Mar 03, 1993
VOICEMODE, ITE, AIR-CONDUCTION HEARING AID
K930541 · ESD
Personal Sound Technologies, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 02, 1993
ACCUMETER(R) CHOLESTEROL SELF-TEST
K914432 · CHH
Chemtrak, Inc.
Chemistry · 515d
Cleared Mar 02, 1993
JMS APHERESIS NEEDLE
K915174 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 473d
Cleared Mar 02, 1993
SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES
K920445 · MHX
Siemens Medical Electronics
Cardiovascular · 392d
Cleared Mar 02, 1993
PHASIS ELECTROMYOGRAPH
K922488 · IKN
Biosound, Inc.
Neurology · 279d
Cleared Mar 02, 1993
LSI SYSTEM IV INTERFERENTIAL,MUSCLE STIMULATOR
K925680 · IPF
M.S.P. , Ltd.
Physical Medicine · 128d
Cleared Mar 02, 1993
OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM
K925961 · IZI
Diagnostic Archives, Inc.
Radiology · 97d
Cleared Mar 02, 1993
PLASMA DISCARD BAGS
K926409 · LKN
Apheresis Technologies, Inc.
Gastroenterology & Urology · 71d
Cleared Mar 01, 1993
CERAPALL 6 -- MODIFIED
K924292 · EJS
Metalor Dental USA Corp.
Dental · 245d
Cleared Mar 01, 1993
VACUPLUS TUBES WITH GREEN STOPPERS
K924361 · JKA
Starplex Scientific, Inc.
Chemistry · 185d
Cleared Mar 01, 1993
VACUPLUS TUBES WITH LAVANDER STOPPERS
K924362 · JKA
Starplex Scientific, Inc.
Chemistry · 185d
Cleared Mar 01, 1993
VACUPLUS TUBES WITH GREY STOPPERS
K924364 · JKA
Starplex Scientific, Inc.
Chemistry · 185d
Cleared Mar 01, 1993
USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
K925074 · DQX
C.R. Bard, Inc.
Cardiovascular · 145d
Cleared Mar 01, 1993
QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL
K925256 · JJY
Quantimetrix Corp.
Hematology · 133d
Cleared Mar 01, 1993
ACCESS HTSH ASSAY
K925637 · JLW
Bio-Rad Laboratories, Inc.
Chemistry · 112d
Cleared Mar 01, 1993
NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY
K925649 · CEC
Solarcare Technologies Corp,Inc.
Chemistry · 112d
Cleared Mar 01, 1993
SOLOS FAN RETRACTORS
K925824 · GCJ
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 104d
Cleared Mar 01, 1993
MULTIFIBREN
K925988 · KQJ
Behring Diagnostics, Inc.
Hematology · 96d
Cleared Mar 01, 1993
BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR
K930310 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 38d
Cleared Mar 01, 1993
BELTONE OPERA LOR, ITC
K930318 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 38d
Cleared Feb 26, 1993
ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC.
K910825 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 744d
Cleared Feb 26, 1993
WILDE ADHESIVE BONDING SYSTEM
K913581 · KLE
Wilde-USA, Inc.
Dental · 564d