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

Filters: Cleared only ×
175,820 results
143977–144000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1986
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
K862218 · KLN
Diagnostic Products Corp.
Chemistry · 16d
Cleared Jun 27, 1986
TSH IRMA KIT
K862249 · JLW
Pacific Biotech, Inc.
Chemistry · 15d
Cleared Jun 26, 1986
FAST FORMALERT
K853555 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 304d
Cleared Jun 26, 1986
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
K860239 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 154d
Cleared Jun 26, 1986
SCHERER PORTABLE TOOTH POLISHER
K860264 · JEQ
Scherer Laboratories, Inc.
Dental · 150d
Cleared Jun 26, 1986
OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
K860673 · DTZ
American Bentley
Cardiovascular · 122d
Cleared Jun 26, 1986
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
K860846 · DTB
Cordis Corp.
Cardiovascular · 112d
Cleared Jun 26, 1986
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
K861422 · DXY
Pacesetter Systems
Cardiovascular · 71d
Cleared Jun 26, 1986
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100
K861428 · DWD
American Omni Medical, Inc.
Cardiovascular · 71d
Cleared Jun 26, 1986
EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM
K861502 · DZE
Dr. Harold Bergman
Dental · 64d
Cleared Jun 26, 1986
HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT
K861846 · EIC
Solar Dental Co., Inc.
Dental · 44d
Cleared Jun 26, 1986
JELTRODE
K861956 · GXY
Henley Intl.
Neurology · 37d
Cleared Jun 26, 1986
MODEL CA, HEARING AID
K862095 · ESD
Fine-Tune
Ear, Nose, Throat · 24d
Cleared Jun 26, 1986
PAP SMEAR KIT
K862242 · HHT
Quali-Med, Inc.
Obstetrics & Gynecology · 14d
Cleared Jun 25, 1986
WRIST ACTIGRAPH
K854030 · GWQ
Ambulatory Monitoring, Inc.
Neurology · 267d
Cleared Jun 25, 1986
BARD-PARKER CAROTID SHUNT
K860136 · DWF
Bd Becton Dickinson Vacutainer...
Cardiovascular · 162d
Cleared Jun 25, 1986
DOUBLE ANTIBODY CALCITONIN RIA KIT
K861274 · JKR
Diagnostic Products Corp.
Chemistry · 79d
Cleared Jun 25, 1986
ALT-30, 60 AND 100
K861366 · CKA
Dimension Diagnostics
Chemistry · 75d
Cleared Jun 25, 1986
ASSERA-PLATE VWF KIT
K861417 · GGP
American Bioproducts Co.
Hematology · 71d
Cleared Jun 25, 1986
ASSERA-PLATE PROTEIN C KIT
K861475 · GGP
American Bioproducts Co.
Hematology · 64d
Cleared Jun 25, 1986
COMPANION LIQUID OXYGEN SYSTEM
K861503 · BYJ
Puritan Bennett Corp.
Anesthesiology · 63d
Cleared Jun 25, 1986
DIRECT BILIRUBIN PROCEDURE
K861671 · CIG
Data Medical Associates, Inc.
Chemistry · 56d
Cleared Jun 25, 1986
THEOPHYLLINE (FPIA) CALIBRATOR KIT
K861768 · JIS
Windsor Laboratories, Inc.
Toxicology · 49d
Cleared Jun 25, 1986
GENTAMICIN (FPIA) CALIBRATOR KIT
K861769 · JIS
Windsor Laboratories, Inc.
Toxicology · 49d