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

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175,820 results
47929–47952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2011
LIFEPAK 15 MONITOR/DEFIBRILLATOR
K103567 · MKJ
Physio-Control, Inc.
Cardiovascular · 106d
Cleared Mar 22, 2011
MIDMARK IQECG
K103640 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 99d
Cleared Mar 22, 2011
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180...
K103696 · FEQ
Erbe USA, Inc.
Gastroenterology & Urology · 95d
Cleared Mar 22, 2011
ORTHOPHOS XG 3D / CEPH
K103711 · OAS
Sirona Dental Systems GmbH
Radiology · 92d
Cleared Mar 22, 2011
MUSTANG BALLOON DILATATION CATHETERS
K103751 · LIT
Boston Scientific
Cardiovascular · 89d
Cleared Mar 22, 2011
SOPRO 281
K103813 · NTN
Sopro
Gastroenterology & Urology · 83d
Cleared Mar 22, 2011
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
K110151 · LNH
Philips Health Care
Radiology · 63d
Cleared Mar 21, 2011
DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS
K100424 · MWI
Danmedical Limited
Cardiovascular · 398d
Cleared Mar 21, 2011
MPACT ACETABULAR SYSTEM
K103721 · LPH
Medacta International
Orthopedic · 90d
Cleared Mar 21, 2011
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES
K110299 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 48d
Cleared Mar 21, 2011
HEM-4030
K110501 · DXN
Omron Healthcare, Inc.
Cardiovascular · 27d
Cleared Mar 18, 2011
LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706
K101792 · ECX
Linde Gas North America, LLC
Anesthesiology · 263d
Cleared Mar 18, 2011
JOULE MULTI-PLATFORM SYSTEM
K101916 · GEX
Sciton, Inc
General & Plastic Surgery · 252d
Cleared Mar 18, 2011
CPR FACE MASK
K102299 · CBP
Genuine First Aid, LLC
Anesthesiology · 217d
Cleared Mar 18, 2011
S9 VPAP ADAPT WITH H5I
K102586 · BZD
Resmed, Ltd.
Anesthesiology · 190d
Cleared Mar 18, 2011
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
K102588 · DRF
Medtronic Ablation Frontiers, LLC
Cardiovascular · 190d
Cleared Mar 18, 2011
EMIT II PLUS6-ACETYLMORPHINE ASSAY
K102779 · DJG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 175d
Cleared Mar 18, 2011
PHILIPS AVALON FETAL MONITOR
K102958 · HGM
Philips Medizin Systeme Boblingen GmbH
Obstetrics & Gynecology · 165d
Cleared Mar 18, 2011
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
K103136 · JEY
Materialise NV
Dental · 144d
Cleared Mar 18, 2011
INTRA SKAN DC
K103579 · EHD
Skanray Technologies
Radiology · 102d
Cleared Mar 18, 2011
LOW PROFILE SCREWS
K103705 · HWC
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 18, 2011
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
K103798 · OQO
Becton, Dickinson & CO
Microbiology · 81d
Cleared Mar 18, 2011
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
K110064 · MNR
Snap Diagnostics, LLC
Anesthesiology · 67d
Cleared Mar 18, 2011
SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE
K110224 · LYZ
Weifang Beihai Color Printing...
General Hospital · 52d