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
74737–74760 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM
K020710 · GKR
Biotest Medizintechnik GmbH
Hematology · 162d
Cleared Aug 14, 2002
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
K020984 · MKJ
Access Cardiosystems, Inc.
Cardiovascular · 149d
Cleared Aug 14, 2002
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · KPS
Cti Pet Systems, Inc.
Radiology · 89d
Cleared Aug 14, 2002
SYNTHES CRANIOFACIAL PLATES
K021642 · JEY
Synthes (Usa)
Dental · 86d
Cleared Aug 14, 2002
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER,...
K021707 · KNW
Senorx, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 14, 2002
BILAYER MATRIX WOUND DRESSING
K021792 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 75d
Cleared Aug 14, 2002
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
K021808 · FZP
Weck
General & Plastic Surgery · 72d
Cleared Aug 14, 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K021898 · FGE
Cordis Corp.
Gastroenterology & Urology · 65d
Cleared Aug 14, 2002
MAEDA SILVER ACUPUNCTURE NEEDLE
K021904 · MQX
Maeda Toyokichi Shoten
General Hospital · 65d
Cleared Aug 14, 2002
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · CBI
Cook, Inc.
Anesthesiology · 64d
Cleared Aug 14, 2002
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
K022017 · LKO
Rhigene, Inc.
Immunology · 55d
Cleared Aug 14, 2002
REGISTRADO X-TRA
K022066 · ELW
Voco GmbH
Dental · 50d
Cleared Aug 14, 2002
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
K022242 · DSY
Intervascular
Cardiovascular · 34d
Cleared Aug 14, 2002
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
K022270 · ODA
Olympus Optical Co., Ltd.
Radiology · 30d
Cleared Aug 14, 2002
STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
K022414 · HAW
Medtronic Surgical Navigation...
Neurology · 21d
Cleared Aug 14, 2002
SCREWLINE
K022425 · DZE
Altatec Biotechnologies N.A., Inc.
Dental · 21d
Cleared Aug 14, 2002
507EL VITAL SIGNS MONITOR
K022435 · DRT
Criticare Systems, Inc.
Cardiovascular · 20d
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486 · DCK
Kamiya Biomedical Co.
Immunology · 16d
Cleared Aug 13, 2002
ELECTROPHYSIOLOGY CATHETER
K012708 · NLH
Alliance Medical Corp.
Cardiovascular · 364d
Cleared Aug 13, 2002
CERALAS D DIODE LASER SYSTEM, MODEL # D50
K013691 · GEX
Biolitec, Inc.
General & Plastic Surgery · 279d
Cleared Aug 13, 2002
GLOVCO EBONY
K013828 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 267d
Cleared Aug 13, 2002
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
K020655 · LZG
Deltec, Inc.
General Hospital · 165d
Cleared Aug 13, 2002
7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630...
K020759 · BZD
Hans Rudolph, Inc.
Anesthesiology · 159d
Cleared Aug 13, 2002
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
K021573 · CBK
Puritan-Bennett
Anesthesiology · 91d