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
149305–149328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1985
OXIDATIVE FORMENTIVE MEDIUM
K851344 · JSH
Micro Media Laboratories
Microbiology · 18d
Cleared Apr 22, 1985
FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP
K851364 · KNW
Precision Dynamics Corp.
Gastroenterology & Urology · 18d
Cleared Apr 19, 1985
VARICELLA-ZOSTER(IGG) IFA TEST
K841434 · GQW
Zeus Scientific, Inc.
Microbiology · 378d
Cleared Apr 19, 1985
TP 1
K844483 · KRG
Vitatron Medical BV
Cardiovascular · 151d
Cleared Apr 19, 1985
CERYX6, 611, CERYX 3 311 & CERYX 1 111
K844485 · KRG
Vitatron Medical BV
Cardiovascular · 151d
Cleared Apr 19, 1985
BIOMETRIC TOTAL HIP SYSTEM
K844787 · JDI
Biomedics
Orthopedic · 130d
Cleared Apr 19, 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025 · KWL
Biomet, Inc.
Orthopedic · 113d
Cleared Apr 19, 1985
MEDICAL, DISPOSABLE BEDDING
K850067 · KME
East Texas Lighthouse For the Blind
General Hospital · 101d
Cleared Apr 19, 1985
DIGITAL IMAGE PROCESSOR FP-2C
K850080 · LLZ
Eigen Video
Radiology · 99d
Cleared Apr 19, 1985
FISHER DIAGNOSTICS LATEST-CRP TEST KIT
K850160 · DCK
Fisher Diagnostics
Immunology · 94d
Cleared Apr 19, 1985
LETOURNEL ACETABULAR PLATE
K850401 · HRS
Pfizer, Inc.
Orthopedic · 77d
Cleared Apr 19, 1985
MEC INTRAMEDULLARY ROD
K850441 · HSB
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
MEC BROAD BONE PLATE
K850442 · HRS
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
MEC BUTRESS PLATE
K850444 · HRS
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
FC-700 DEFIBRILLATOR
K850618 · LDD
Fukuda Denshi USA, Inc.
Cardiovascular · 63d
Cleared Apr 19, 1985
OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE
K850623 · DTB
Oscor Medical Corp.
Cardiovascular · 59d
Cleared Apr 19, 1985
INTERMEDICS BONE SCREW
K850770 · HWC
Intermedics Orthopedics
Orthopedic · 53d
Cleared Apr 19, 1985
COMPRESSION HIP SCREW SYSTEM
K850886 · KIT
Pfizer, Inc.
Pathology · 46d
Cleared Apr 19, 1985
HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER
K851078 · DYB
Hdc Corp.
Cardiovascular · 32d
Cleared Apr 19, 1985
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
K851145 · DTD
Pacesetter Systems
Cardiovascular · 29d
Cleared Apr 19, 1985
NUMED BALLOON PACING CATHETER
K851246 · LDF
NuMED, Inc.
Cardiovascular · 25d
Cleared Apr 19, 1985
AMENDMENT LIFEPAK 200, NPN 046
K851247 · DRO
Physio-Control Corp.
Cardiovascular · 43d
Cleared Apr 19, 1985
AMENDMENT LIFEPAK 100, NPN 045
K851248 · DRO
Physio-Control Corp.
Cardiovascular · 43d
Cleared Apr 19, 1985
MICROSPIRO-SDS
K851277 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 18d