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
76057–76080 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 04, 2002
BIOSUC
K013108 · KNW
Hakko Medical Co., Ltd.
Gastroenterology & Urology · 199d
Cleared Apr 04, 2002
TRUWAVE
K013210 · GZJ
Dan Med, Inc.
Neurology · 190d
Cleared Apr 04, 2002
RESECTION ABLATOR
K013369 · GEI
Linvatec Corp.
General & Plastic Surgery · 175d
Cleared Apr 04, 2002
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
K013428 · HAW
Ohio Medical Instrument Co., Inc.
Neurology · 170d
Cleared Apr 04, 2002
ORTHOPILOT 2
K013569 · HAW
Aesculap, Inc.
Neurology · 157d
Cleared Apr 04, 2002
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
K013988 · BSN
Millipore Corp.
Anesthesiology · 121d
Cleared Apr 04, 2002
MEDICAL LE
K020058 · LLZ
Barco N.V.
Radiology · 86d
Cleared Apr 04, 2002
GYRUS ENT SOMNOPLASTY GENERATOR
K020067 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 85d