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

Filters: Cleared only ×
176,076 results
61705–61728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2006
SPECTRUM M2 MONITOR
K062468 · DRY
Spectrum Medical, Llp
Cardiovascular · 20d
Cleared Sep 12, 2006
ZEUS MALE CONDOM APPLICATOR
K052206 · HIS
Condax, LLC
Obstetrics & Gynecology · 396d
Cleared Sep 12, 2006
OPTECURE +CCC
K061668 · MBP
Exactech, Inc.
Orthopedic · 90d
Cleared Sep 12, 2006
GO GO MINI, MODEL SC30
K062160 · INI
Pride Mobility Products Corp.
Physical Medicine · 46d
Cleared Sep 12, 2006
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · KWL
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Sep 12, 2006
VERTE-STACK SPINAL SYSTEM
K062427 · MQP
Medtronic Sofamor Danek
Orthopedic · 25d
Cleared Sep 12, 2006
INCORIS ZI
K062509 · EIH
Sirona Dental Systems GmbH
Dental · 15d
Cleared Sep 11, 2006
ENDOFAST RELIANT SYSTEM
K060329 · FTL
Endogun Medical Systems
General & Plastic Surgery · 214d
Cleared Sep 11, 2006
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
K061432 · KNT
Hospira, Inc.
Gastroenterology & Urology · 110d
Cleared Sep 11, 2006
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
K061471 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 108d
Cleared Sep 11, 2006
RENALSOFT
K061515 · KPF
Baxter Healthcare Corp
Gastroenterology & Urology · 102d
Cleared Sep 11, 2006
BOSWORTH DENTIN RESIN
K061611 · KLE
Harry J. Bosworth Co.
Dental · 94d
Cleared Sep 11, 2006
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
K061648 · NPJ
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Sep 11, 2006
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · NBC
Dade Behring, Inc.
Chemistry · 80d
Cleared Sep 11, 2006
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2...
K061802 · NQD
Dade Behring, Inc.
Chemistry · 76d
Cleared Sep 11, 2006
SYNTHES 3.5MM SPRING PLATE
K061973 · HRS
Synthes (Usa)
Orthopedic · 61d
Cleared Sep 11, 2006
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062022 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 56d
Cleared Sep 11, 2006
BIOPSY DIGIT-AM
K062039 · IZH
Giotto USA, LLC
Radiology · 54d
Cleared Sep 11, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
K062058 · NBW
Bayer Healthcare
Chemistry · 53d
Cleared Sep 11, 2006
VOYAGER PACS SYSTEM
K062062 · LLZ
Voyager Imaging
Radiology · 53d
Cleared Sep 11, 2006
SFX SNAP-FIT CROSS CONNECTOR
K062196 · MNH
Depuy Spine, Inc.
Orthopedic · 41d
Cleared Sep 11, 2006
CTC WORKSTATION, MODEL 2200
K062229 · LLZ
Medical Diagnostic Technologies, Inc.
Radiology · 40d
Cleared Sep 11, 2006
MODIFICATION TO DIADEXUS PLAC TEST
K062234 · NOE
Diadexus, Inc.
Chemistry · 40d
Cleared Sep 11, 2006
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · CFR
Roche Diagnostics Corp.
Chemistry · 40d