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
81001–81024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 17, 2001
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
K003583 · NDW
Trace America, Inc.
Chemistry · 58d
Cleared Jan 17, 2001
HYALURONIDASE REAGENT, MODEL CAT#2212
K003751 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 43d
Cleared Jan 17, 2001
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING...
K003895 · KGO
Ansell Perry
General Hospital · 30d
Cleared Jan 17, 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · DQO
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jan 16, 2001
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
K003745 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 43d
Cleared Jan 16, 2001
ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT...
K003771 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 41d