FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86713–86736 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1999
NORMED BONE TRANSPORT
K990140 · JEY
Ace Surgical Supply Co., Inc.
Dental · 65d
Cleared Mar 25, 1999
WILSON-COOK BIPOLAR PROBE
K990145 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 25, 1999
PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT
K990208 · MEG
Science Incorporated
General Hospital · 63d
Cleared Mar 25, 1999
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257 · HKX
Keeler Instruments, Inc.
Ophthalmic · 57d
Cleared Mar 25, 1999
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND...
K990438 · MGP
Dermaphylyx, Inc.
General & Plastic Surgery · 42d
Cleared Mar 25, 1999
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
K990456 · KPI
Hollister, Inc.
Gastroenterology & Urology · 41d
Cleared Mar 25, 1999
PEREGRINE WET SET, MODEL PD400.00
K990518 · FRN
Peregrine Surgical , Ltd.
General Hospital · 35d
Cleared Mar 25, 1999
IGG FLEX REAGENT CARTRIDGE
K990551 · CFQ
Dade Behring, Inc.
Immunology · 31d
Cleared Mar 25, 1999
IMMUNOGLOBULIN A TEST SYSTEM
K990552 · CFQ
Dade Behring, Inc.
Immunology · 31d
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