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
79873–79896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 17, 2001
PROFILE-ER
K002331 · DIS
Medtox Diagnostics, Inc.
Toxicology · 169d
Cleared Jan 17, 2001
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
K002638 · CKG
Future Diagnostics B.V.
Chemistry · 146d
Cleared Jan 17, 2001
ELECSYS DHEA-S
K003174 · JKC
Roche Diagnostics Corp.
Chemistry · 99d
Cleared Jan 17, 2001
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
K003278 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 17, 2001
PHLEBOPUMP, MODEL 1000
K003284 · JOW
Prevent Products, Inc.
Cardiovascular · 90d
Cleared Jan 17, 2001
MAXILLARY DISTRACTOR
K003393 · JEY
Synthes (Usa)
Dental · 77d
Cleared Jan 17, 2001
NC-STAT
K003508 · JXE
Neurometrix, Inc.
Neurology · 64d
Cleared Jan 17, 2001
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
K003556 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Jan 17, 2001
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K003575 · LNI
GE Medical Systems
Radiology · 58d