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
42769–42792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2012
RESTORELLE L
K122440 · OTO
Coloplast Corp.
Obstetrics & Gynecology · 101d
Cleared Nov 19, 2012
ACUMED PELVIC BONE PLATE SYSTEM
K122538 · HRS
Acumed, LLC
Orthopedic · 90d
Cleared Nov 19, 2012
SENTRYSUITE PRODUCT LINE
K122699 · BTY
Carefusion Germany 234 GmbH
Anesthesiology · 76d
Cleared Nov 16, 2012
ENDOSSEOUS DENTAL IMPLANT
K113113 · DZE
Ot Medical GmbH
Dental · 393d
Cleared Nov 16, 2012
STEREOS WORKSTATION
K113344 · LLZ
Eos Imaging
Radiology · 368d
Cleared Nov 16, 2012
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED....
K120066 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 312d
Cleared Nov 16, 2012
PRO-LINK CERVICAL SPACER SYSTEM
K121151 · OVE
Life Spine, Inc.
Orthopedic · 214d
Cleared Nov 16, 2012
HAMILTON-C2
K121225 · CBK
Hamilton Medical AG
Anesthesiology · 207d
Cleared Nov 16, 2012
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
K121792 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 141d
Cleared Nov 16, 2012
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
K122008 · OVE
Incite Innovation, LLC
Orthopedic · 130d
Cleared Nov 16, 2012
SPHYGMOCOR XCEL
K122129 · DXN
Atcor Medical
Cardiovascular · 121d
Cleared Nov 16, 2012
MS SA IMPLANT SYSTEM
K122171 · DZE
Osstem Implant Co., Ltd.
Dental · 116d
Cleared Nov 16, 2012
PEDIATRIC POSITIONER PAD SET
K122174 · KXH
Ge Healthcare Coils (Usa Instruments,...
Radiology · 116d
Cleared Nov 16, 2012
VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY...
K122236 · JAQ
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Nov 16, 2012
360 GAS ASSISTED ENDOSCOPIC APPLICATOR
K122526 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 88d
Cleared Nov 16, 2012
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
K122529 · HSX
Zimmer, Inc.
Orthopedic · 88d
Cleared Nov 16, 2012
ACCU-CHEK ULTRAFLEX INFUSION SET
K122686 · FPA
Roche Diabetes Care AG
General Hospital · 73d
Cleared Nov 16, 2012
ABL90 FLEX
K122729 · CHL
Radiometer Medical Aps
Chemistry · 71d
Cleared Nov 16, 2012
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING...
K123026 · LYY
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Nov 16, 2012
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
K123174 · LLZ
Ge Healthcare
Radiology · 37d
Cleared Nov 16, 2012
CD HORIZON SPIRE Z SPINAL SYSTEM
K123246 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 15, 2012
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
K113380 · GEI
Medtronic, Inc.
General & Plastic Surgery · 365d
Cleared Nov 15, 2012
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728 · MBP
Hans Biomed Corp.
Orthopedic · 332d
Cleared Nov 15, 2012
FEMMYCYCLE
K121857 · HHE
Femcap Incorporated
Obstetrics & Gynecology · 142d