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
71953–71976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2003
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K032281 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Aug 06, 2003
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K032329 · IYN
Medison America, Inc.
Radiology · 8d
Cleared Aug 05, 2003
DIGITAL TEMPERATURE MONITOR
K030219 · FLL
Kang Ying Medical Appliances, Inc.
General Hospital · 195d
Cleared Aug 05, 2003
LIFESYNE SYSTEMS
K030795 · DRG
Gmp/Companies, Inc.
Cardiovascular · 146d
Cleared Aug 05, 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
K031282 · LJT
LeMaitre Vascular, Inc.
General Hospital · 105d
Cleared Aug 05, 2003
CARRIER TIPS
K031461 · ELC
Dentsply Intl.
Dental · 89d
Cleared Aug 05, 2003
ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
K031472 · CGA
Lifescan, Inc.
Chemistry · 88d
Cleared Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
K031717 · CDZ
Roche Diagnostics Corp.
Chemistry · 63d
Cleared Aug 05, 2003
COLTOSOL F
K031752 · EMA
Coltene/Whaledent, Inc.
Dental · 61d
Cleared Aug 05, 2003
PRECISET DAT PLUS I CALIBRATORS
K031775 · DKB
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Aug 05, 2003
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
K031786 · EOX
Vision-Sciences, Inc.
Ear, Nose, Throat · 56d
Cleared Aug 05, 2003
SAFEPRO PLUS SAFETY SYRINGE
K031830 · MEG
Formosa Medical Devices, Inc.
General Hospital · 53d
Cleared Aug 05, 2003
PULPDENT ETCH-RITE ROYALE
K031915 · KLE
Pulpdent Corporation
Dental · 46d
Cleared Aug 05, 2003
TINA-QUANT CRP (LATEX)
K032336 · DCN
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Aug 05, 2003
UNITY NETWORK IS PATIENT VIEWER
K032346 · MSX
Ge Medical Systems Information...
Cardiovascular · 6d
Cleared Aug 04, 2003
GLUCOLEADER VALUE
K023279 · NBW
Hmd Biomedical, Inc.
Chemistry · 307d
Cleared Aug 04, 2003
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
K023548 · DQY
Velocimed
Cardiovascular · 286d
Cleared Aug 04, 2003
BONESOURCE BVF
K031435 · MQV
Howmedica Osteonics
Orthopedic · 90d
Cleared Aug 04, 2003
SQUEEZE-EASE MAMMOGRAPHY CUSHION
K031574 · IZH
S & S X-Ray Products, Inc.
Radiology · 76d
Cleared Aug 04, 2003
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM...
K031759 · DKZ
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Aug 01, 2003
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
K012715 · NLF
Hygia Health Services, Inc.
Anesthesiology · 717d
Cleared Aug 01, 2003
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
K014241 · NCX
Alsius Corp.
Neurology · 583d
Cleared Aug 01, 2003
CARDIODIRECT, MODELS 12M, 12I, 12S
K024283 · DPS
Reynolds Medical , Ltd.
Cardiovascular · 221d
Cleared Aug 01, 2003
R 72
K030487 · KPW
Ralco S.R.L.
Radiology · 168d