FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73273–73296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 186d
Cleared Nov 18, 2002
IDI-STREP B ASSAY
K022504 · NJR
Infectio Diagnostic, Inc.
Microbiology · 112d
Cleared Nov 18, 2002
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
K022671 · LZA
Hartalega Sdn Bhd
General Hospital · 98d
Cleared Nov 18, 2002
MILLENNIUM MICROSURGICAL SYSTEM
K022760 · GEX
Bausch & Lomb, Inc.
General & Plastic Surgery · 90d
Cleared Nov 18, 2002
AMEDITECH IMMUTEST HCG PREGANCY TEST
K023126 · LCX
Ameditech, Inc.
Chemistry · 60d
Cleared Nov 18, 2002
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K023184 · DIC
Bayer Diagnostics Corp.
Chemistry · 55d
Cleared Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310,...
K023337 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 42d
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