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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140833–140856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1987
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
K864166 · LKW
Weck Surgical Systems
Neurology · 110d
Cleared Feb 10, 1987
SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA
K864199 · CCK
Salter Labs
Anesthesiology · 106d
Cleared Feb 10, 1987
MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT
K864349 · LJT
C.R. Bard, Inc.
General Hospital · 98d
Cleared Feb 10, 1987
COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR
K864654 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 74d
Cleared Feb 10, 1987
SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH
K864707 · ELM
Ivoclar USA, Inc.
Dental · 70d
Cleared Feb 10, 1987
IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL
K864709 · EBI
Ivoclar USA, Inc.
Dental · 70d
Cleared Feb 10, 1987
ISOSIT N
K864710 · EBF
Ivoclar USA, Inc.
Dental · 70d
Cleared Feb 10, 1987
MEDI-TRACE INFANT ELECTRODE
K864722 · DRX
Graphic Controls Corp.
Cardiovascular · 69d
Cleared Feb 10, 1987
HALL ORAL IMPLANT SYSTEM
K864734 · DZE
Hall Surgical, Division of Zimmer, Inc.
Dental · 68d
Cleared Feb 10, 1987
TELAMAT
K864749 · JAA
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 67d
Cleared Feb 10, 1987
MODIFIED VINYLAC PRESS PACK DENTURE RESIN
K864757 · EBI
Astron Dental Corp.
Dental · 67d
Cleared Feb 10, 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580
K864809 · FRN
Y
General Hospital · 63d
Cleared Feb 10, 1987
AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2
K864821 · EOB
Reichert-Jung, Inc.
Ear, Nose, Throat · 63d
Cleared Feb 10, 1987
A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
K864826 · EJH
Austenal Dental, Inc.
Dental · 63d
Cleared Feb 10, 1987
DENTAL FLOSS
K864832 · JES
Westone Products , Ltd.
Dental · 63d
Cleared Feb 10, 1987
3F ELECTRODE
K864904 · FFK
Northgate Research, Inc.
Gastroenterology & Urology · 57d
Cleared Feb 10, 1987
TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
K864960 · GCQ
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 10, 1987
AFT(R) HEP PERFORMANCE EVALUATION PROGRAM
K865019
Behring Diagnostics, Inc.
Immunology · 49d
Cleared Feb 10, 1987
SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE
K865047 · BYG
Salter Labs
Anesthesiology · 48d
Cleared Feb 10, 1987
GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP
K865051 · FRN
Panamedix, Inc.
General Hospital · 48d
Cleared Feb 10, 1987
ACCU-FLO REGULATOR
K865077 · CAN
Alum-Ox, Inc.
Anesthesiology · 43d
Cleared Feb 10, 1987
N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE
K865108 · BSR
Ackrad Laboratories
Anesthesiology · 41d
Cleared Feb 10, 1987
MR590 DUAL HOSE HEATER POWER PACK
K870055 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 34d
Cleared Feb 10, 1987
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS
K870107 · DBF
Diagnostic Products Corp.
Immunology · 29d