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
126745–126768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1990
HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY
K901094 · JEY
Grimm & Norton
Dental · 51d
Cleared Apr 27, 1990
BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY
K901095 · JEY
Grimm & Norton
Dental · 51d
Cleared Apr 27, 1990
AMALGAM CONDENSER
K901178 · EKJ
American Medical Ceramics, Inc.
Dental · 45d
Cleared Apr 27, 1990
AMALCAP PLUS
K901256 · EJJ
Ivoclar North America, Inc.
Dental · 43d
Cleared Apr 27, 1990
SEARS MODEL 9094 ITE HEARING AID
K901350 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 27, 1990
SEARS MODEL 9098 ITE HEARING AID
K901351 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 27, 1990
CHEM-SLEEVE
K901629 · KME
Haz-Med, Inc.
General Hospital · 28d
Cleared Apr 26, 1990
TELEMETRY POWER PACK MODEL 2
K891927 · FCP
Lucas & Rhea Mfg.
Gastroenterology & Urology · 394d
Cleared Apr 26, 1990
ENDOCOAGULATOR 2001 KLI
K895402 · HGI
Cabot Medical Corp.
Obstetrics & Gynecology · 231d
Cleared Apr 26, 1990
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538 · LYK
Trimedyne, Inc.
Cardiovascular · 225d
Cleared Apr 26, 1990
CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT
K896555 · KPQ
W. L. Systems, Inc.
Radiology · 160d
Cleared Apr 26, 1990
NEUROTENS
K896620 · GZJ
Henley Intl.
Neurology · 156d
Cleared Apr 26, 1990
MODEL ECG100 SIMULATOR
K897029 · DPS
Dynatech/Nevada, Inc.
Cardiovascular · 129d
Cleared Apr 26, 1990
TRAMSCOPE SYSTEM
K900598 · DPS
Marquette Electronics, Inc.
Cardiovascular · 77d
Cleared Apr 26, 1990
MODIFIED MODEL 5401B TEST CABLE
K900622 · DXY
Medtronic Vascular
Cardiovascular · 77d
Cleared Apr 26, 1990
MAXI COMPRESSORS
K900686 · BTI
Medical Industries America, Inc.
Anesthesiology · 72d
Cleared Apr 26, 1990
TECHNICON TESTPOINT(TM) LIGAND CONTROL
K900717 · JJY
Technicon Instruments Corp.
Chemistry · 71d
Cleared Apr 26, 1990
CMV-IGM IFA TEST SYSTEM
K900743 · LKQ
Zeus Scientific, Inc.
Microbiology · 69d
Cleared Apr 26, 1990
DIGITAL CUFF PV GAUGE
K900755 · BSK
International Medical Products, Inc.
Anesthesiology · 69d
Cleared Apr 26, 1990
'APNEA-ELECTRODE'
K900826 · BZQ
Medical Science Products, Inc.
Anesthesiology · 64d
Cleared Apr 26, 1990
HYCOR ACCUPINCH PHENCYCLIDINE TEST
K900921 · LCM
Hycor Biomedical, Inc.
Toxicology · 58d
Cleared Apr 26, 1990
MODIFIED TECHNICON DPA-1(TM) SYSTEM
K900943 · DEW
Technicon Instruments Corp.
Immunology · 57d
Cleared Apr 26, 1990
SURGILASE SL50 SURGICAL LASER SYSTEM
K901211 · GEX
Surgilase, Inc.
General & Plastic Surgery · 43d
Cleared Apr 26, 1990
SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120
K901227 · GEX
Surgilase, Inc.
General & Plastic Surgery · 43d