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
84217–84240 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
K990111 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
K990112 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND...
K990113 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
K990115 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
TYRODE'S SOLUTION-ACIDIFIED
K991339 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 231d
Cleared Dec 06, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY,...
K992188 · JNM
Nichols Institute Diagnostics
Immunology · 160d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · GFO
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · GFO
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Dec 06, 1999
COLON ALERT TEST
K992759 · KHE
Immunostics Inc.,
Hematology · 111d
Cleared Dec 06, 1999
QUANTITATIVE SENTINEL SYSTEM
K993008 · HGM
Marquette Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 06, 1999
SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030,...
K993073 · MAI
Bionx Implants, Ltd.
Orthopedic · 83d
Cleared Dec 06, 1999
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
K993255 · FRG
Coltene/Whaledent, Inc.
General Hospital · 69d
Cleared Dec 06, 1999
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K993304 · DHR
Cogent Diagnotics , Ltd.
Immunology · 63d
Cleared Dec 06, 1999
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
K993309 · MMI
Bayer Corp.
Chemistry · 63d
Cleared Dec 06, 1999
SYNTHES LIGHT GUIDE
K993314 · FQP
Synthes (Usa)
General & Plastic Surgery · 63d
Cleared Dec 06, 1999
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
K993353 · MMI
Bayer Corp.
Chemistry · 62d
Cleared Dec 06, 1999
MANUAL BONE MARROW BIOPSY DEVICE
K993435 · KNW
Promex, Inc.
Gastroenterology & Urology · 55d
Cleared Dec 06, 1999
OMNISONIC ENDOSCOPIC DEFLECTOR
K993445 · GCM
Omnisonics Medical Technologies
Gastroenterology & Urology · 55d
Cleared Dec 06, 1999
K-ASSAY FIBRINOGEN
K993482 · GIS
Kamiya Biomedical Co.
Hematology · 53d
Cleared Dec 06, 1999
V-SUPRAGOLD, ALLOY NO. 5024
K993507 · EJT
Metalor Dental USA Corp.
Dental · 52d
Cleared Dec 06, 1999
V-SUPRA PLUS, ALLOY NO. 5025
K993508 · EJT
Metalor Dental USA Corp.
Dental · 52d
Cleared Dec 06, 1999
PROMPTFLOW
K993566 · EBF
Espe Dental AG
Dental · 46d
Cleared Dec 06, 1999
AED LAPAROSCOPE
K993688 · GCJ
National Advanced Endoscopy Devices,...
General & Plastic Surgery · 35d
Cleared Dec 06, 1999
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS...
K993808 · MNH
Interpore Cross Intl.
Orthopedic · 26d