FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86209–86232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1999
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT...
K990639 · DQX
Guidant Corp.
Cardiovascular · 27d
Cleared Mar 25, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE...
K990783 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 16d
Cleared Mar 24, 1999
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
K982136 · DTN
Schiff & Co.
Cardiovascular · 280d
Cleared Mar 24, 1999
IBC FLOPUMP, MODEL 6000
K983272 · KFM
International Biophysics Corp.
Cardiovascular · 188d
Cleared Mar 24, 1999
VASCULAR OCCLUSION SYSTEM
K983483 · HCG
Cordis Neurovascular, Inc.
Neurology · 170d
Cleared Mar 24, 1999
SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229
K984062 · DYB
Diag Corp.
Cardiovascular · 128d
Cleared Mar 24, 1999
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE...
K990682 · EKX
Nsk Nakanishi, Inc.
Dental · 21d
Cleared Mar 23, 1999
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
K980737 · GGT
Nichols Institute Diagnostics
Hematology · 391d
Cleared Mar 23, 1999
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
K983229 · OMA
Olympic Medical Corp.
Neurology · 189d
Cleared Mar 23, 1999
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT,...
K983346 · DQX
Guidant Corp.
Cardiovascular · 181d
Cleared Mar 23, 1999
ACTIWATCH
K983533 · GWQ
Mini-Mitter Co., Inc.
Neurology · 166d
Cleared Mar 23, 1999
DR180-R/OXY
K983576 · FLL
North East Monitoring, Inc.
General Hospital · 161d
Cleared Mar 23, 1999
ABLATOR ELECTRODE
K983652 · HRX
Linvatec Corp.
Orthopedic · 155d
Cleared Mar 23, 1999
CHEMO MINI SPIKE PLUS
K983794 · LHI
B. Braun of America, Inc.
General Hospital · 147d
Cleared Mar 23, 1999
CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR
K983986 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 134d
Cleared Mar 23, 1999
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138 · LSR
Zeus Scientific, Inc.
Microbiology · 125d
Cleared Mar 23, 1999
RANDOX ALBUMIN
K984494 · CIX
Randox Laboratories, Ltd.
Chemistry · 96d
Cleared Mar 23, 1999
SYNERGY D2 SPINAL IMPLANTS
K984578 · MNI
Interpore Cross Intl.
Orthopedic · 90d
Cleared Mar 23, 1999
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
K990013 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 78d
Cleared Mar 23, 1999
LACTOSORB BONE PIN
K990291 · HTY
Biomet, Inc.
Orthopedic · 53d
Cleared Mar 23, 1999
DEPUY ACE SPIDER PLATE
K990392 · HRS
Depuy Ace Medical Co.
Orthopedic · 42d
Cleared Mar 23, 1999
THE.R.MO.FREE
K990448 · EBI
Dentamax, Inc.
Dental · 39d
Cleared Mar 23, 1999
HERMES OPERATING ROOM CONTROL CENTER
K990691 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 20d
Cleared Mar 23, 1999
SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM
K990746 · LYY
Southland Products Co., Ltd.
General Hospital · 15d