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
162721–162744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1981
PDS* ABSORBABLE LIGATING CLIPS
K812323 · FZP
Ethicon, Inc.
General & Plastic Surgery · 91d
Cleared Nov 16, 1981
VTS-1000 VISUAL TESTING SYSTEM
K812331 · HLX
Nicolet Biomedical Instruments
Ophthalmic · 90d
Cleared Nov 16, 1981
SURGICAL PAWS
K812388 · GDJ
Berkeley Medevices
General & Plastic Surgery · 88d
Cleared Nov 16, 1981
SURGICAL LOOPS
K812389 · GAD
Berkeley Medevices
General & Plastic Surgery · 88d
Cleared Nov 16, 1981
SYNTHEMED PULSE GENERATOR VVI MODEL 1000
K812464 · DXY
Synthemed Corp.
Cardiovascular · 77d
Cleared Nov 16, 1981
DISPOSABLE SUTURE REMOVAL SCISSORS
K812555 · JOK
Medcare Products
General Hospital · 69d
Cleared Nov 16, 1981
DIAGNOSTIC MEDICAL COMPUTER
K812638 · DXG
Diagnostic Resources, Inc.
Cardiovascular · 62d
Cleared Nov 16, 1981
LIFESPAN CO2
K812643 · CCK
Biochem International, Inc.
Anesthesiology · 61d
Cleared Nov 16, 1981
SKI 5000
K812646 · DXK
Smithkline Diagnostics, Inc.
Cardiovascular · 60d
Cleared Nov 16, 1981
SILICONE IMPLANTS
K812691 · MDM
Sutter Biomedical, Inc.
General & Plastic Surgery · 55d
Cleared Nov 16, 1981
MILLER/NADLER GLARE TESTER
K812706 · HOS
Mosebach Electric & Supply
Ophthalmic · 53d
Cleared Nov 16, 1981
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD
K812725 · LDF
Medtronic Vascular
Cardiovascular · 49d
Cleared Nov 16, 1981
BOUNDARY PROCESS CHANGE
K812738 · KKX
The Buckeye Cellulose Corp.
General Hospital · 48d
Cleared Nov 16, 1981
FETAL VITABILITY TM MODE
K812743 · IYO
Technicare Corp.
Radiology · 48d
Cleared Nov 16, 1981
MODEL 535-03 TRACE A PACE
K812755 · DXH
Intermedics, Inc.
Cardiovascular · 47d
Cleared Nov 16, 1981
DATASCRIBE #DS-40
K812765 · BXW
Timeter Instrument Corp.
Anesthesiology · 42d
Cleared Nov 16, 1981
VANCE-AMBROSE RESECTOSCOPE FORCEPS
K812785 · GEN
Vance Products, Inc.
General & Plastic Surgery · 42d
Cleared Nov 16, 1981
RIND AIRWAY
K812822 · CAE
Rind Medical Development
Anesthesiology · 39d
Cleared Nov 16, 1981
ORBIC* SPHERICAL ALLOY
K812827 · EJJ
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Nov 16, 1981
MODEL 2000 MONITOR
K812828 · DRT
Datascope Corp.
Cardiovascular · 39d
Cleared Nov 16, 1981
SURGICAL SUCTION INSTRUMENTS-DISPOS.
K812845 · GCX
Abco Dealers, Inc.
General Hospital · 38d
Cleared Nov 16, 1981
MEDICON #8200 AMS
K812873 · BZQ
Medicon, Inc.
Anesthesiology · 33d
Cleared Nov 16, 1981
ENDODONTIC PAPER POINTS
K812886 · EKN
United Dental Mfg., Inc.
Dental · 33d
Cleared Nov 16, 1981
HEMASITE GRAFTLESS VASCULAR ACESS
K812890 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 32d