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
163225–163248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1981
DEFIBRILLATOR/MONITOR
K812317 · LDD
Hewlett-Packard Co.
Cardiovascular · 35d
Cleared Sep 21, 1981
INTK-08 8 FRENCH INTRODUCER KIT W/SIDE
K812325 · DYB
Sorensen Research
Cardiovascular · 35d
Cleared Sep 21, 1981
ZEE EXTRICATION DEVICE
K812342 · IQF
Zee Medical Products Co., Inc.
Physical Medicine · 34d
Cleared Sep 21, 1981
PRECIOUS-METAL/PLASTIC ATTACH., AUXILL
K812360 · EGG
Zl-Microdent-Attachments
Dental · 32d
Cleared Sep 21, 1981
PRESET FLOWMETER
K812419 · CAX
Timeter Instrument Corp.
Anesthesiology · 28d
Cleared Sep 21, 1981
LENSINE EXTRA STRENGTH CLEANER
K812433 · HPX
CooperVision, Inc.
Ophthalmic · 27d
Cleared Sep 21, 1981
KOI DIAMOND KNIFE
K812450 · HNN
Koi, Inc.
Ophthalmic · 24d
Cleared Sep 21, 1981
HIFLO-HP
K812457 · FPB
Tri-Med, Inc.
General Hospital · 21d
Cleared Sep 21, 1981
VARIOUS AURAL GROMMETS
K812460 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 21d
Cleared Sep 21, 1981
MINI O2
K812513 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 19d
Cleared Sep 21, 1981
IMPROVED PLAYTEX TAMPON
K812534 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 18d
Cleared Sep 21, 1981
RELIANCE OPHTHALMIC INSTRUMENT CONTROL
K812544 · HMF
F. & F. Koenigkramer
Ophthalmic · 17d
Cleared Sep 18, 1981
SURFACE REPLACEMENT HIP PROSTHESIS
K811718 · KYB
Biomet, Inc.
Ophthalmic · 92d
Cleared Sep 18, 1981
ULTRASONIC TIPS
K812126 · HQC
CooperVision, Inc.
Ophthalmic · 53d
Cleared Sep 17, 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550 · KKX
3M Company
General Hospital · 441d
Cleared Sep 16, 1981
GLYCOHEMOGLOBIN
K810958 · LCP
Macomb Chemical Co.
Toxicology · 161d
Cleared Sep 16, 1981
CARDIACMONITORS
K811425 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 117d
Cleared Sep 16, 1981
MANUFACTURING PROCESS CHANGE
K811441 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 117d
Cleared Sep 16, 1981
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K811567 · LCP
Ortho Diagnostic Systems, Inc.
Hematology · 104d
Cleared Sep 16, 1981
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
K811671 · GQH
Zeus Scientific, Inc.
Microbiology · 93d
Cleared Sep 16, 1981
GORE-TEX CARDIOVASCULAR PATCH
K811841 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1981
MICROCOIL 150 DIALYZER
K811974 · FHS
Erika, Inc.
Hematology · 65d
Cleared Sep 16, 1981
DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING
K812014 · IYO
Elscint, Inc.
Radiology · 61d
Cleared Sep 16, 1981
MEDTRONIC ENERTRAX MODEL 7100
K812096 · DXY
Medtronic Vascular
Cardiovascular · 54d