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
82585–82608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2000
J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR
K001298 · IOR
Roll-Ability (Pty) , Ltd.
Physical Medicine · 85d
Cleared Jul 18, 2000
DASH 3000/4000 PATIENT MONITOR
K001359 · DSI
General Electric Medical Systems...
Cardiovascular · 81d
Cleared Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 71d
Cleared Jul 18, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K001573 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Jul 18, 2000
PASCO MIC AND MIC/ID PANELS
K001612 · JWY
Pasco Laboratories, Inc.
Microbiology · 54d
Cleared Jul 18, 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K001843 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 18, 2000
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
K001964 · MRC
Lobob Laboratories, Inc.
Ophthalmic · 21d
Cleared Jul 18, 2000
CA GUARD, LTD. PSP (PORT SITE PROTECTOR)
K992182 · GCJ
Ca Guard, Ltd.
General & Plastic Surgery · 386d
Cleared Jul 18, 2000
SURGILIGHT, INC EXCIMER LASER
K993328 · GEX
Surgilight, Inc.
General & Plastic Surgery · 288d
Cleared Jul 18, 2000
BIOPACK
K993685 · ILY
Bioscan, Inc.
Physical Medicine · 260d
Cleared Jul 18, 2000
LIGHT PATCH
K993686 · ILY
Bioscan, Inc.
Physical Medicine · 260d
Cleared Jul 17, 2000
RIZA BAND STRETCHER (RBS)-60000
K001236 · FHN
R-Med, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 17, 2000
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
K001268 · MHX
General Electric Medical Systems...
Cardiovascular · 88d
Cleared Jul 17, 2000
MEDICAL IMAGE MERGE (MIM)
K001276 · KPS
Syntermed, Inc.
Radiology · 87d
Cleared Jul 17, 2000
SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
K001296 · ITH
Cavendish Scott, Inc.
Physical Medicine · 84d
Cleared Jul 17, 2000
INTRODUCER SHEATH
K001328 · FEC
Novasys Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Jul 17, 2000
KARL STORZ 3D VIDEO SYSTEM
K001362 · GCI
Karl Storz Imaging, Inc.
General & Plastic Surgery · 80d
Cleared Jul 17, 2000
ACCUSONIC PLUS, MODEL AP-100
K001370 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 77d
Cleared Jul 17, 2000
ACCUSET SENSOR, MODEL 2000
K001386 · FEN
Pelvicare, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 17, 2000
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K001582 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Jul 17, 2000
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
K001698 · FFS
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 45d
Cleared Jul 17, 2000
GC FUJICEM
K001730 · EMA
GC America, Inc.
Dental · 40d
Cleared Jul 17, 2000
ARTHROCARE FLOW CONTROL UNIT
K001904 · GEI
Arthrocare Corp.
General & Plastic Surgery · 25d
Cleared Jul 17, 2000
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · MEG
Univec, Inc.
General Hospital · 236d