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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122929–122952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1991
IPG-II MODULE
K903700 · DSB
Life Sciences Manufacturing, Inc.
Cardiovascular · 154d
Cleared Jan 16, 1991
RHEOLOGIC I
K903711 · IPF
Advanced Rehabilitative Technology, Inc.
Physical Medicine · 155d
Cleared Jan 16, 1991
NEUROMED TS8 TEST STIMULATOR
K903814 · GZB
Neuromed, Inc.
Neurology · 149d
Cleared Jan 16, 1991
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
K903823 · KGX
Smith and Nephew Donjoy, Inc.
General & Plastic Surgery · 149d
Cleared Jan 16, 1991
BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
K904282 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 120d
Cleared Jan 16, 1991
STEALTH DILATION CATHETER SYSTEM/MODIFICATION
K904287 · DYG
Target Therapeutics
Cardiovascular · 124d
Cleared Jan 16, 1991
F.T.I. MEDICAL LIGHT GUIDE
K904378 · EQH
Fiberoptics Technology, Inc.
Ear, Nose, Throat · 114d
Cleared Jan 16, 1991
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
K904801 · KGC
Orion Life Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jan 16, 1991
AUTOWAND(TM) 7XXX SERIES, MODIFICATION
K904888 · CAC
Boehringer Laboratories
Anesthesiology · 82d
Cleared Jan 16, 1991
CONDOR DIGITAL INFLATION SYRINGE
K904954 · MAV
Professional Medical Services
Cardiovascular · 72d
Cleared Jan 16, 1991
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
K904965 · FSY
Smith & Nephew Equipment Group
General & Plastic Surgery · 72d
Cleared Jan 16, 1991
LAB-SITE SAFETY NEEDLE
K905018 · DQO
Telos Medical Corp.
Cardiovascular · 70d
Cleared Jan 16, 1991
MIDIGOLD 50
K905322 · EJT
Ivoclar North America, Inc.
Dental · 49d
Cleared Jan 16, 1991
HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR
K905393 · FWF
Frigitronics, Inc.
General & Plastic Surgery · 47d
Cleared Jan 16, 1991
AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE
K905587 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 34d
Cleared Jan 16, 1991
ECLIPSE ICA BUN
K905602 · CDQ
Biotope, Inc.
Chemistry · 34d
Cleared Jan 15, 1991
THE O-RING SYSTEM - ORS
K900099 · DZE
Attachments Intl., Inc.
Dental · 372d
Cleared Jan 15, 1991
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
K903344 · DSP
Kontron Instruments, Inc.
Cardiovascular · 174d
Cleared Jan 15, 1991
HAWAIIAN SUPRACONDYLAR PLATE
K903697 · HRS
Medpac
Orthopedic · 153d
Cleared Jan 15, 1991
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
K903733 · LBR
Institute For Clinical Applications
Chemistry · 152d
Cleared Jan 15, 1991
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
K904777 · DRS
Baxter Healthcare Corp
Cardiovascular · 85d
Cleared Jan 15, 1991
AVI MODEL 600 SYRINGE PUMP, MODIFICATION
K904979 · FRN
3M Avi, Inc.
General Hospital · 76d
Cleared Jan 15, 1991
CLOSED SYSTEM FLUSH SET
K904994 · DXT
Argon Medical Corp.
Cardiovascular · 69d
Cleared Jan 15, 1991
LAB-SITE
K905017 · DQO
Telos Medical Corp.
Cardiovascular · 69d