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
74401–74424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2002
SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN
K023635 · FYA
Sri/Surgical Express, Inc.
General Hospital · 20d
Cleared Nov 18, 2002
GORE 3.0T TORSO ARRAY
K023679 · MOS
W.L. Gore & Associates, Inc.
Radiology · 17d
Cleared Nov 15, 2002
VITALSAT SERIES
K011518 · DQA
Beta Biomed Services, Inc.
Anesthesiology · 547d
Cleared Nov 15, 2002
CALGITROL AG SILVER ALGINATE WOUND DRESSING
K011618 · FRO
Adri
General & Plastic Surgery · 539d
Cleared Nov 15, 2002
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K013913 · NFA
Medtronic Percusurge, Inc.
Cardiovascular · 353d
Cleared Nov 15, 2002
ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE,...
K022821 · DZK
Ideatrics, Inc.
Dental · 81d
Cleared Nov 15, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
K022982 · HNO
Med-Logics, Inc.
Ophthalmic · 67d
Cleared Nov 15, 2002
HERMES OPERATING ROOM CONTROL CENTER
K023095 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 58d
Cleared Nov 15, 2002
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
K023268 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 46d
Cleared Nov 15, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K023558 · CHH
Polymer Technology Systems, Inc.
Chemistry · 23d
Cleared Nov 15, 2002
PHASEAL
K023747 · LHI
Carmel Pharma Ab.
General Hospital · 7d
Cleared Nov 14, 2002
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
K021470 · MWJ
General Electric Medical Systems...
Cardiovascular · 190d
Cleared Nov 14, 2002
LUTHER SAFETY HUBER NEEDLE SET
K021565 · FPA
Luther Research Partners
General Hospital · 185d
Cleared Nov 14, 2002
VENTED CEMENT RESTRICTOR
K022729 · JDX
Amedica Corp.
Orthopedic · 90d
Cleared Nov 14, 2002
V TENS PLUS
K022731 · GZJ
Body Clock Health Care, Ltd.
Neurology · 90d
Cleared Nov 14, 2002
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A...
K022740 · MLD
Datex-Ohmeda
Cardiovascular · 87d
Cleared Nov 14, 2002
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K022753 · JOW
Medical Device Services
Cardiovascular · 87d
Cleared Nov 14, 2002
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
K022900 · JEQ
John O. Butler Co.
Dental · 72d
Cleared Nov 14, 2002
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
K022934 · BZD
Gottlieb Weinmann Geraete Fuer...
Anesthesiology · 71d
Cleared Nov 14, 2002
CARDIOTOUCH-3000
K023034 · LOS
Bionet Company, Ltd.
Cardiovascular · 63d
Cleared Nov 14, 2002
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
K023434 · LHQ
Dorex, Inc.
Radiology · 30d
Cleared Nov 14, 2002
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF...
K023437 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Nov 14, 2002
SKINTACT ECG ELECTRODE
K023503 · DRX
Leonhard Lang GmbH
Cardiovascular · 27d
Cleared Nov 13, 2002
HEX-LOCK TEMPORARY ABUTMENT
K014050 · DZE
Sulzer Dental, Inc.
Dental · 338d