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
76657–76680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2002
MARK 5000 QUADRATURE SHOULDER COIL
K013854 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Feb 06, 2002
POWDERFREE LATEX SURGEON'S GLOVES
K013914 · KGO
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 71d
Cleared Feb 06, 2002
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K014169 · FIP
Bob J. Johnson & Assoc., Inc.
Gastroenterology & Urology · 49d
Cleared Feb 06, 2002
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
K014187 · CAC
Boehringer Laboratories
Anesthesiology · 47d
Cleared Feb 06, 2002
MODIFICATION TO GEO STRUCTURE
K020048 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 06, 2002
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
K020084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 27d
Cleared Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · GGC
Sigma Diagnostics, Inc.
Hematology · 26d
Cleared Feb 06, 2002
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN...
K020168 · LON
Dade Behring, Inc.
Microbiology · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE...
K020173 · LON
Dade Behring, Inc.
Microbiology · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN...
K020182 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN...
K020185 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN...
K020209 · LON
Dade Behring, Inc.
Microbiology · 15d
Cleared Feb 06, 2002
R & D BODY FLUID CONTROL
K020229 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25,...
K020246 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Feb 06, 2002
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
K020249 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Feb 06, 2002
LOGIQ 3
K020263 · IYN
General Electric Co.
Radiology · 12d
Cleared Feb 05, 2002
CENTRIFUGAL PUMP
K011838 · DWA
Stockert Instrumente GmbH
Cardiovascular · 238d
Cleared Feb 05, 2002
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
K012274 · LDD
Medtronic Physio-Control Corp.
Cardiovascular · 201d
Cleared Feb 05, 2002
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE...
K012463 · GXY
Everyway Medical Instruments Co.,Ltd
Neurology · 188d
Cleared Feb 05, 2002
VASCUPUNCTURE ACCESS WIRE
K012861 · DQX
Neometrics, Inc.
Cardiovascular · 165d
Cleared Feb 05, 2002
TRAPSYSTEM SET
K013692 · KNW
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 90d
Cleared Feb 05, 2002
ORTHOSIS HELMET MOLDING
K013700 · MVA
Precision Prosthetics & Orthotics, Inc.
Neurology · 89d
Cleared Feb 05, 2002
BECKER BAND CRANIAL REMOLDING ORTHOSIS
K013719 · MVA
Becker Orthopedic Appliance Co.
Neurology · 89d
Cleared Feb 05, 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891 · DZE
Institut Straumann AG
Dental · 74d