FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80377–80400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2001
RENEW NEUROSTIMULATION SYSTEM
K000852 · GZF
Advanced Neuromodulation Systems
Neurology · 310d
Cleared Jan 19, 2001
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE...
K000884 · NDZ
Becton Dickinson Biosciences
Microbiology · 305d
Cleared Jan 19, 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061 · DRT
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Jan 19, 2001
OTI CERAMIC FEMORAL HEAD SYSTEM
K003316 · LZO
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Jan 19, 2001
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
K003358 · KPS
Smv America
Radiology · 85d
Cleared Jan 19, 2001
ACROTHERM
K003368 · DWJ
Aquarius Medical Corp.
Cardiovascular · 81d
Cleared Jan 19, 2001
EDTA ROOT CANAL CLEANSER
K003422 · KJJ
Super Glide, Inc.
Dental · 77d
Cleared Jan 19, 2001
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
K003481 · LMC
Codonics, Inc.
Radiology · 71d
Cleared Jan 19, 2001
NETRA WORKSTATION AND NETRAMD SOFTWARE
K003484 · LLZ
Scimage, Inc.
Radiology · 71d
Cleared Jan 19, 2001
HARDYDISK TRIMETHOPRIM 5MCG
K003554 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Jan 19, 2001
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND...
K003964 · DTK
Cordis Corp.
Cardiovascular · 28d
Cleared Jan 19, 2001
SPLINE DENTAL IMPLANT SYSTEM
K010073 · DZE
Sulzer Calcitek, Inc.
Dental · 10d
Cleared Jan 18, 2001
ACTIVE ARRAY CATHETER, MODEL CS-2000
K001097 · MOS
Image-Guided Neurologics, Inc.
Radiology · 289d
Cleared Jan 18, 2001
PC FLOW +
K001528 · BZG
Spirometrics Medical Equipment Co.
Anesthesiology · 246d
Cleared Jan 18, 2001
SYMPHONY GRAFT DELIVERY SYSTEM
K003286 · LYC
Depuyacromed
Dental · 90d
Cleared Jan 18, 2001
MAMMOTOME HAND HELD PROBE, MODEL MHH8
K003297 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 18, 2001
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
K003453 · LNH
Fonar Corp.
Radiology · 72d
Cleared Jan 18, 2001
A1-CS-SB Y-ADAPTER, MODEL 124 871
K003454 · DTD
Biotronik, Inc.
Cardiovascular · 72d
Cleared Jan 18, 2001
U-SYSTEMS ULTRASOUND SYSTEM USI-2000
K003479 · IYN
U-Systems, Inc.
Radiology · 70d
Cleared Jan 18, 2001
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING
K003492 · DQK
Cambridge Heart, Inc.
Cardiovascular · 66d
Cleared Jan 18, 2001
MRI LINE MARKER
K003736 · JAK
I.Z.I. Corp.
Radiology · 45d
Cleared Jan 18, 2001
VIVID 7 WITH SONOPAC, MODEL FB0008XX
K003931 · IYN
Ge Medical Systems, Inc.
Radiology · 29d
Cleared Jan 18, 2001
TRAK BACK II
K003938 · DQO
Jomed, Inc.
Cardiovascular · 29d
Cleared Jan 17, 2001
LIFEMATE HEMOFILTRATION SYSTEM
K001283 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 271d