Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
64969–64992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 2005
MODIFICATION TO ACCU-CHEK GO SYSTEM
K051592 · LFR
Roche Diagnostics Corp.
Chemistry · 79d
Cleared Sep 02, 2005
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
K051593 · KNY
Acmi Corporation
Gastroenterology & Urology · 78d
Cleared Sep 02, 2005
MCCARTNEY ACCESS TUBE
K051594 · HEW
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 78d
Cleared Sep 02, 2005
RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY
K051671 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 72d
Cleared Sep 02, 2005
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
K051874 · OLW
Physiometrix, Inc.
Neurology · 53d
Cleared Sep 02, 2005
MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER
K051910 · ELC
D.B.I. America Corp.
Dental · 50d
Cleared Sep 02, 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)
K051924 · LYZ
Shijiazhuang Manful Light Industrial...
General Hospital · 49d
Cleared Sep 02, 2005
DAR-8000I
K052076 · IZI
Shimadzu Medical Systems
Radiology · 32d
Cleared Sep 02, 2005
EDWARDS PERIPHERAL DILATION CATHETER
K052149 · DQY
Edwards Lifesciences, LLC
Cardiovascular · 25d
Cleared Sep 02, 2005
CLIRPATH TURBO EXCIMER LASER CATHETERS
K052296 · PDU
Spectranetics Corp.
Cardiovascular · 10d
Cleared Sep 02, 2005
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
K052334 · ELC
Dentsply Intl.
Dental · 7d
Cleared Sep 01, 2005
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
K050352 · JTO
Ameritek Research, LLC
Chemistry · 202d
Cleared Sep 01, 2005
SYNTHOGRAFT
K051091 · LYC
Bicon, Inc.
Dental · 126d
Cleared Sep 01, 2005
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
K051157 · KCT
Micromedics, Inc.
General Hospital · 119d
Cleared Sep 01, 2005
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
K051264 · FPA
Unomedical A/S
General Hospital · 108d
Cleared Sep 01, 2005
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
K051422 · FLL
Medisim, Ltd.
General Hospital · 92d
Cleared Sep 01, 2005
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
K051515 · DYB
Acumen Medical, Inc.
Cardiovascular · 85d
Cleared Sep 01, 2005
AVANA DENTAL IMPLANT SYSTEM
K051576 · DZE
Osstem Co., Ltd.
Dental · 79d
Cleared Sep 01, 2005
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K051669 · LHI
Migada Plant
General Hospital · 71d
Cleared Sep 01, 2005
MODEL 2800 PFT FILTER
K051712 · BZG
Air Safety, Ltd.
Anesthesiology · 66d
Cleared Sep 01, 2005
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
K051838 · DQY
Concentric Medical, Inc.
Cardiovascular · 56d
Cleared Sep 01, 2005
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX...
K052016 · LYY
Sgmp Co., Ltd.
General Hospital · 37d
Cleared Sep 01, 2005
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
K052017 · MKW
Dade Behring, Inc.
Toxicology · 37d
Cleared Sep 01, 2005
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS
K052074 · MRC
Szabocsik and Associates
Ophthalmic · 31d