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

Filters: Cleared only ×
176,076 results
61177–61200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2006
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062839 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 49d
Cleared Nov 09, 2006
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K062884 · LYZ
Suqian Green Glove Co., Ltd.
General Hospital · 44d
Cleared Nov 09, 2006
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K062955 · LYY
Pt. Haloni Jane
General Hospital · 41d
Cleared Nov 09, 2006
AEQUALIS SHOULDER SYSTEM
K063081 · HSD
Tornier
Orthopedic · 30d
Cleared Nov 09, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
K063102 · LRG
Dade Behring, Inc.
Microbiology · 30d
Cleared Nov 09, 2006
COLOR LCD MONITOR, RADIFORCE, MODEL RX210
K063120 · LLZ
Eizo Nanao Corporation
Radiology · 28d
Cleared Nov 09, 2006
S-SCAN MRI SYSTEM
K063207 · LNH
Esaote, S.P.A.
Radiology · 17d
Cleared Nov 09, 2006
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION
K063241 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 09, 2006
3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC
K063266 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 10d
Cleared Nov 09, 2006
ISITE PACS, V 4. X
K063267 · LLZ
Stentor Inc., A Philips Medical...
Radiology · 10d
Cleared Nov 08, 2006
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
K061848 · MUD
Hypermed, Inc.
Cardiovascular · 131d
Cleared Nov 08, 2006
HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0
K061905 · DQK
Medcon , Ltd.
Cardiovascular · 126d
Cleared Nov 08, 2006
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
K061935 · DXN
Sensacare , Ltd.
Cardiovascular · 121d
Cleared Nov 08, 2006
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)
K062127 · DRG
Medic4all (Israel) , Ltd.
Cardiovascular · 106d
Cleared Nov 08, 2006
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS...
K062228 · HAW
Zimmer, Inc.
Neurology · 98d
Cleared Nov 08, 2006
IRIDEX OCULIGHT TX
K062369 · GEX
Iridex Corp
General & Plastic Surgery · 86d
Cleared Nov 08, 2006
K-ETCHANT GEL
K062409 · EBF
Kuraray Medical, Inc.
Dental · 83d
Cleared Nov 08, 2006
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
K062930 · NCF
Alcon Research, Ltd.
Ophthalmic · 41d
Cleared Nov 07, 2006
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D,...
K052599 · HLJ
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 412d
Cleared Nov 07, 2006
HEPASPHERE MICROSPHERES
K052742 · KRD
Biosphere Medical, Inc.
Neurology · 403d
Cleared Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 111d
Cleared Nov 07, 2006
ART SHIELDED BREAST APPLICATOR
K062135 · JAQ
Advanced Radiation Therapy, LLC
Radiology · 104d
Cleared Nov 07, 2006
HUMERAL HEAD, MANUAL DRIVER
K062422 · FMI
Vidacare Corporation
General Hospital · 81d
Cleared Nov 07, 2006
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
K062440 · LSL
Gen-Probe, Inc.
Microbiology · 78d