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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
38113–38136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2014
APLIO ARTIDA, V3.2
K140729 · IYN
Toshiba America Medical Systems, In.C
Radiology · 60d
Cleared May 23, 2014
VIVID T8/VIVID T8 PRO
K141067 · IYN
Ge Healthcare
Radiology · 29d
Cleared May 23, 2014
TIGHTRAIL MINI
K141131 · DRE
Spectranetics, Inc.
Cardiovascular · 22d
Cleared May 22, 2014
SYNERGY
K123876 · NPM
Odontit S.A.
Dental · 521d
Cleared May 22, 2014
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K131588 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 356d
Cleared May 22, 2014
EV1000 CLINICAL PLATFORM
K131892 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 331d
Cleared May 22, 2014
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
K132681 · MEG
Sol-Millennium Medical, Inc.
General Hospital · 267d
Cleared May 22, 2014
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT,...
K133121 · QSY
Sam Medical Products
General & Plastic Surgery · 234d
Cleared May 22, 2014
ZOLL X SERIES
K133269 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 210d
Cleared May 22, 2014
NEXUS NIS-6P LUER ACTIVATED DEVICE
K133351 · FPA
Nexus Medical, LLC
General Hospital · 203d
Cleared May 22, 2014
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
K133790 · NBW
Andon Health Co, Ltd.
Chemistry · 164d
Cleared May 22, 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
K140027 · JWH
Materialise NV
Orthopedic · 136d
Cleared May 22, 2014
CARPENTIER BI-CAVAL FEMORAL CANNULA
K140192 · DWF
Medtronic, Inc.
Cardiovascular · 115d
Cleared May 22, 2014
ISE INDIRECT NA, K, C1 FOR GEN 2
K140373 · JGS
Roche Diagnostics
Chemistry · 97d
Cleared May 22, 2014
ANS1 SOFTWARE
K140412 · DXN
Ld Technology, LLC
Cardiovascular · 93d
Cleared May 22, 2014
ANTHRACIS REAL-TIME PCR ASSAY
K140426 · NHT
Centers For Disease Control and...
Microbiology · 92d
Cleared May 22, 2014
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared May 22, 2014
CAPTIA MEASLES IGM
K140455 · PCL
Trinity Biotech USA
Microbiology · 87d
Cleared May 22, 2014
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND...
K140522 · JJY
Randox Laboratories Limited
Chemistry · 79d
Cleared May 22, 2014
EVEREST SPINAL SYSTEM
K140529 · NKB
K2m, LLC
Orthopedic · 79d
Cleared May 22, 2014
SALVATION 3DI PLATING SYSTEM
K140792 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared May 22, 2014
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
K141220 · NSU
Thermo Fisher Scientific (Life...
Microbiology · 10d
Cleared May 21, 2014
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
K131609 · HSB
Xiamen Double Engine Medical Material...
Orthopedic · 352d
Cleared May 21, 2014
SOLUM IV BONE VOID FILLER
K132470 · MQV
Spinesmith Partners, Llp
Orthopedic · 287d