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
82561–82584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2000
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR,...
K000660 · DRO
Medical Data Electronics
Cardiovascular · 29d
Cleared Mar 28, 2000
WESCO BLANKET
K981093 · DWJ
Wesco, Inc.
Cardiovascular · 733d
Cleared Mar 28, 2000
GAS FILTER
K993060 · JOD
Olson Medical Sales, Inc.
Cardiovascular · 197d
Cleared Mar 28, 2000
UCLA/UNIVERSAL ABUTMENT
K993129 · DZE
Diamodent
Dental · 190d
Cleared Mar 28, 2000
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
K993199 · CAF
Ferraris Medical, Inc.
Anesthesiology · 187d
Cleared Mar 28, 2000
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
K994194 · JBP
Cardiovascular Diagnostics, Inc.
Hematology · 106d
Cleared Mar 28, 2000
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
K994278 · CIN
Beckman Coulter, Inc.
Chemistry · 99d
Cleared Mar 28, 2000
AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K994423 · DXN
Vsm Medtech , Ltd.
Cardiovascular · 90d
Cleared Mar 28, 2000
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
K994430 · MSX
General Electric Medical Systems...
Cardiovascular · 90d
Cleared Mar 27, 2000
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
K000060 · GDW
Senorx, Inc.
General & Plastic Surgery · 77d
Cleared Mar 27, 2000
RETIC CHEX LINEARITY
K000115 · JPK
Streck Laboratories, Inc.
Hematology · 73d
Cleared Mar 27, 2000
MFCD 118
K000291 · LLZ
Barco N.V.
Radiology · 56d
Cleared Mar 27, 2000
MFCD 120
K000294 · LLZ
Barco N.V.
Radiology · 56d
Cleared Mar 27, 2000
VENTRICULAR ANALYSIS TOOLKIT OPTION
K000315 · LNH
GE Medical Systems
Radiology · 55d
Cleared Mar 27, 2000
NOVA CORDLESS CURING LIGHT
K000393 · EBZ
Nova/Da Vinci Systems, Inc.
Dental · 49d
Cleared Mar 27, 2000
RANDOX COMPLEMENT C4
K000468 · DBI
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Mar 27, 2000
RANDOX COMPLEMENT C3
K000469 · CZW
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Mar 27, 2000
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
K000600 · KLI
Syva Co., Dade Behring, Inc.
Chemistry · 33d
Cleared Mar 27, 2000
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
K983214 · GXD
Rita Medical Systems
Neurology · 560d
Cleared Mar 27, 2000
MLC FIT
K991133 · IYE
Impac Medical Systems, Inc.
Radiology · 360d
Cleared Mar 27, 2000
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K992303 · MUJ
Nucletron Corp.
Radiology · 263d
Cleared Mar 27, 2000
MCA-601, C-ARM MOBILE
K993896 · JAA
Medison Radiology Systems, Inc.
Radiology · 132d
Cleared Mar 27, 2000
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K994389 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Mar 24, 2000
AESCULAP BONE WAX
K000021 · MTJ
Aesculap, Inc.
General & Plastic Surgery · 80d