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
57001–57024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2008
AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.
K071517 · MMK
A.B.M. Italia S.P.A
General Hospital · 303d
Cleared Apr 02, 2008
LD-I 75 AND LD-I 200
K072551 · NHN
Meditech International, Inc.
Physical Medicine · 205d
Cleared Apr 02, 2008
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
K073445 · DXN
Taidoc Technology Corporation
Cardiovascular · 117d
Cleared Apr 02, 2008
MIMICS
K073468 · LLZ
Materialise NV
Radiology · 114d
Cleared Apr 02, 2008
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND...
K073494 · NBW
Taidoc Technology Corporation
Chemistry · 112d
Cleared Apr 02, 2008
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM
K080191 · KWQ
Depuy Spine, Inc.
Orthopedic · 68d
Cleared Apr 02, 2008
ONCOBIONIC SYSTEM
K080376 · OAB
Oncobionic Incorporated
General & Plastic Surgery · 50d
Cleared Apr 02, 2008
CONMED LINVATEC OSPREY DRILL SYSTEM
K080444 · HBC
Conmed Linvatec
Neurology · 43d
Cleared Apr 02, 2008
BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
K080557 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 34d
Cleared Apr 02, 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593 · FLL
Taidoc Technology Corporation
General Hospital · 30d
Cleared Apr 02, 2008
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
K080622 · EOB
Optim, Inc.
Ear, Nose, Throat · 28d
Cleared Apr 02, 2008
ERBE VIO ESU, MODEL VIO 200 S
K080715 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 20d
Cleared Apr 02, 2008
AESCULAP ENDOSCOPIC CLIP SYTEM
K080753 · FZP
Aesculap, Inc.
General & Plastic Surgery · 16d
Cleared Apr 02, 2008
WBR XPRESS.CARDIAC, WBR XPRESS.BONE
K080784 · KPS
Ultraspect , Ltd.
Radiology · 13d
Cleared Apr 02, 2008
TEM 3002G- HN DUAL TUNE HEAD COIL
K080820 · MOS
Mr Instruments, Inc.
Radiology · 9d
Cleared Apr 01, 2008
DUREX PLAY SOFT & SENSUAL LUBRICANT
K071626 · NUC
Ssl Americas
Obstetrics & Gynecology · 292d
Cleared Apr 01, 2008
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
K072658 · DCN
Siemens Medical Solutions Diagnostics
Immunology · 194d
Cleared Apr 01, 2008
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
K073137 · NBW
Apex BioTechnology Corp.
Chemistry · 146d
Cleared Apr 01, 2008
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K073434 · DYB
Bipore, Inc.
Cardiovascular · 117d
Cleared Apr 01, 2008
VPAP ST
K080131 · BZD
Resmed, Ltd.
Anesthesiology · 74d
Cleared Mar 31, 2008
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
K070310 · NTM
Brahms Aktiengesellschaft
Microbiology · 424d
Cleared Mar 31, 2008
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
K073075 · DZE
Dentsply International, Inc.
Dental · 152d
Cleared Mar 31, 2008
RESPIRATORY HUMIDIFIER, MODEL MR850
K073706 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 91d
Cleared Mar 31, 2008
INREACH SYSTEM
K080271 · JAK
Superdimension, Ltd.
Radiology · 59d