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
83713–83736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 06, 1999
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
K993854 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 21d
Cleared Dec 06, 1999
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
K993907 · MHD
Agilent Technologies, Inc.
General Hospital · 19d
Cleared Dec 03, 1999
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
K981655 · DQA
Spacelabs Medical, Inc.
Anesthesiology · 571d
Cleared Dec 03, 1999
HL148 & HL168
K990807 · DXN
Health & Life Co., Ltd.
Cardiovascular · 267d
Cleared Dec 03, 1999
PRIMUS STEAM STERILIZERS
K991575 · FLE
Primus Sterilizer Co., Inc.
General Hospital · 211d
Cleared Dec 03, 1999
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
K992992 · KPS
Toshiba America Medical Systems, In.C
Radiology · 87d
Cleared Dec 03, 1999
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED &...
K993001 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 87d
Cleared Dec 03, 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM -...
K993454 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 51d
Cleared Dec 03, 1999
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
K993708 · OLX
Biomagnetic Technologies, Inc.
Neurology · 30d