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
52705–52728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2009
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
K083074 · OAH
Advandx, Inc.
Microbiology · 282d
Cleared CT Jul 24, 2009
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411
K083105 · IPF
Bio-Medical Research, Ltd.
Physical Medicine · 277d
Cleared Jul 24, 2009
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
K083294 · NUA
Nanosphere, Inc.
Pathology · 256d
Cleared Jul 24, 2009
MR-TOUCH OPTION
K083421 · LNH
Ge Medical Systems, LLC
Radiology · 247d
Cleared Jul 24, 2009
IMAGINE TC SKIN THERAPY SYSTEM
K083461 · GEI
Endymion Medical, Ltd.
General & Plastic Surgery · 245d
Cleared Jul 24, 2009
JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000
K090007 · CAW
Danyang Jumao Healthcare Equipment...
Anesthesiology · 203d
Cleared Jul 24, 2009
REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412,...
K090438 · DQA
Envitec-Wismar GmbH
Anesthesiology · 154d
Cleared Jul 24, 2009
BENACEL
K090612 · OLR
Unicare Biomedical
General & Plastic Surgery · 140d
Cleared Jul 24, 2009
E-STATIS 40 SYSTEM
K090937 · EBW
Scican , Ltd.
Dental · 112d
Cleared Jul 24, 2009
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
K091110 · MNH
Spinal Edge, LLC
Orthopedic · 98d
Cleared Jul 24, 2009
THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS
K091141 · DWL
Knit-Rite, Inc.
General Hospital · 95d
Cleared Jul 24, 2009
70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
K091185 · CAH
Hsiner Co., Ltd.
General Hospital · 92d
Cleared Jul 24, 2009
RAMP RSV ASSAY
K091235 · GQG
Response Biomedical Corp.
Microbiology · 88d
Cleared Jul 24, 2009
EXTRAFIX EXTERNAL FIXATION SYSTEM
K091258 · KTT
Qfx Technologies, Inc.
Orthopedic · 86d
Cleared Jul 24, 2009
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL...
K091294 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 81d
Cleared Jul 24, 2009
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
K091454 · DJG
Medtox Diagnostics, Inc.
Toxicology · 67d
Cleared Jul 24, 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6,...
K091513 · DPS
Edan Instruments, Inc.
Cardiovascular · 63d
Cleared Jul 24, 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
K091577 · HWC
Extremity Medical, LLC
Orthopedic · 52d
Cleared Jul 24, 2009
PICA WHOLE BODY MRI SYSTEM
K091580 · LNH
Time Medical Limited
Radiology · 52d
Cleared Jul 24, 2009
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
K091985 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 22d
Cleared Jul 24, 2009
ELATION MB METAL REINFORCED PLASTIC BRACKET
K092030 · DYW
Dentsply Interntional
Dental · 18d
Cleared Jul 23, 2009
SAS INFLUENZA A & B TEST
K080380 · PSZ
Sa Scientific, Inc.
Microbiology · 526d
Cleared Jul 23, 2009
UNIVERSAL, AESTHETICA, NATEA, NATURA
K083670 · DZE
Euroteknika
Dental · 224d
Cleared Jul 23, 2009
SOLO INSULIN PATCH PUMP
K090245 · LZG
Medingo , Ltd.
General Hospital · 171d