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
76657–76680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 2002
STRATASIS SLING KIT
K020654 · PAG
Cook Biotech, Inc.
Gastroenterology & Urology · 40d
Cleared Apr 09, 2002
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K020832 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Apr 09, 2002
MODEL GT010706 ELECTRONIC THERMOMETER
K021052 · FLL
Global Treasure Industries , Ltd.
General Hospital · 8d
Cleared Apr 08, 2002
MONITORING SYSTEM,MODEL ARGUS PB-1000
K012226 · MHX
Schiller AG
Cardiovascular · 266d
Cleared Apr 08, 2002
HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330,...
K012417 · JOW
Hygia Health Services, Inc.
Cardiovascular · 252d
Cleared Apr 08, 2002
AL-2000 COMBINED BIOMETER AND PACHYMETER
K012803 · IYO
Tomey Corp.
Radiology · 230d
Cleared Apr 08, 2002
BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
K013672 · JEY
Azary Technologies, LLC
Dental · 153d
Cleared Apr 08, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
K013848 · IYN
U-Systems, Inc.
Radiology · 139d
Cleared Apr 08, 2002
HDR MIAMI APPLICATOR
K020176 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Apr 08, 2002
SURGIC IV IMPLANT CONTROL UNIT
K020327 · EBW
Nakanishi, Inc.
Dental · 67d
Cleared Apr 08, 2002
CHEMISTRY CALIBRATOR
K020454 · JIT
Jas Diagnostics, Inc.
Chemistry · 56d
Cleared Apr 08, 2002
MODEL GT980201 ELECTRONIC THERMOMETER
K021028 · FLL
Global Treasure , Ltd.
General Hospital · 10d
Cleared Apr 05, 2002
HISONIC-TRD TINNITUS RELIEF DEVICE
K013253 · KLW
Hearing Innovations, Inc.
Ear, Nose, Throat · 189d
Cleared Apr 05, 2002
RUBICOR BREAST BIOPSY DEVICE
K020047 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 88d
Cleared Apr 05, 2002
VIRIDIS DERMA LASER
K020071 · GEX
Quantel Medical
General & Plastic Surgery · 86d
Cleared Apr 05, 2002
NETLINK/NETSCAN
K020213 · DXH
Rozinn Electronics, Inc.
Cardiovascular · 73d
Cleared Apr 05, 2002
SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2
K020252 · FMF
Harvest Technologies, Corp.
General Hospital · 71d
Cleared Apr 05, 2002
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
K020548 · CEC
Monobind
Chemistry · 45d
Cleared Apr 05, 2002
ENVISION ANTERIOR CERVICAL PLATE SYSTEM
K020649 · KWQ
Ortho Development Corp.
Orthopedic · 36d
Cleared Apr 05, 2002
MIETHKE SHUNT SYSTEM
K020728 · HCA
Aesculap, Inc.
Neurology · 30d
Cleared Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 28d
Cleared Apr 05, 2002
HL168F
K020766 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Apr 05, 2002
KING OF HEARTS EXPRESS + AF MONITOR
K020825 · DSH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 22d
Cleared Apr 04, 2002
ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH...
K013088 · IYO
Echotech 3D Imaging Systems, Inc.
Radiology · 199d