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
44833–44856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2012
VISIA ONCOLOGY
K120484 · LLZ
Mevis Medical Solutions AG
Radiology · 39d
Cleared Mar 27, 2012
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE...
K120504 · DIF
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Mar 27, 2012
BRIVO MR355
K120778 · LNH
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 13d
Cleared Mar 26, 2012
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
K110535 · FRN
Carefusion 303, Inc.
General Hospital · 395d
Cleared Mar 26, 2012
VENUS SPINAL FIXATION SYSTEM
K120270 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 56d
Cleared Mar 26, 2012
BIOPLEX 2200 TORC IGG
K120572 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 28d
Cleared Mar 23, 2012
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
K103704 · LRK
Zephyr Sleep Technologies, Inc.
Dental · 459d
Cleared Mar 23, 2012
BIOLIS 12I
K110520 · CEM
Tokyo Boeki Medisys, Inc.
Chemistry · 394d
Cleared Mar 23, 2012
I-LIPO SYSTEM
K111501 · OLI
Chromogenex Technologies Limited
General & Plastic Surgery · 297d
Cleared Mar 23, 2012
RESORB X-G
K112064 · JEY
KLS-Martin L.P.
Dental · 248d
Cleared Mar 23, 2012
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
K112377 · CFR
Shenzhen Mindray Bio-Medical...
Chemistry · 219d
Cleared Mar 23, 2012
GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
K112469 · HAW
Sonowand AS
Neurology · 210d
Cleared Mar 23, 2012
BLADDER SCANNER
K113304 · IYO
MEDA Co., Ltd.
Radiology · 136d
Cleared Mar 23, 2012
SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX
K113733 · HRS
Neoortho Produtos Ortopedicos S/A
Orthopedic · 95d
Cleared Mar 23, 2012
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
K113748 · HBL
Imris, Inc.
Radiology · 93d
Cleared Mar 23, 2012
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
K113866 · KGN
Brennen Medical, LLC
General & Plastic Surgery · 84d
Cleared Mar 23, 2012
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K120049 · PSZ
Becton, Dickinson and Company
Microbiology · 77d
Cleared Mar 23, 2012
PALLS M SPINAL SYSTEM
K120538 · MNI
Korea Bone Bank Co., Ltd.
Orthopedic · 30d
Cleared Mar 23, 2012
MYOSURE CONTROL UNIT
K120593 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 24d
Cleared Mar 23, 2012
APACERAM BONE GRAFT SUBSTITUTE
K120602 · MQV
Hoya Corporation
Orthopedic · 24d
Cleared Mar 23, 2012
SPECULUM, VAGINAL, NONMETAL
K120743 · HIB
Welch Allyn, Inc.
Obstetrics & Gynecology · 11d
Cleared Mar 22, 2012
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET...
K111702 · LKN
Fenwal, Inc.
Gastroenterology & Urology · 279d
Cleared CT Mar 22, 2012
VISI MOBILE MONITORING SYSTEM
K112478 · MWI
Sotera Wireless, Inc.
Cardiovascular · 206d
Cleared Mar 22, 2012
EZSLEEP SLEEP QUALITY RECORDER
K112573 · MWJ
Platinum Team Co., Ltd.
Cardiovascular · 198d