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
91345–91368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1997
ADJUSTABLE THERASNORE
K973038 · LRK
Distar, Inc.
Dental · 90d
Cleared Nov 12, 1997
BONE GRAFT SCREW SYSTEM
K973056 · DZL
Bicon, Inc.
Dental · 89d
Cleared Nov 12, 1997
1.4 FR MAPCATH SENSOR STYLET
K973057 · LJS
Navion Biomedical Corp.
General Hospital · 89d
Cleared Nov 12, 1997
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
K973131 · LMD
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Nov 12, 1997
HEART ACCESS PLUS CARDIAC EVENT RECORDER
K973141 · DXH
Paceart, Inc.
Cardiovascular · 83d
Cleared Nov 12, 1997
BONE GRAFT HARVESTER
K973560 · HWE
Ds Mfg., Inc.
Orthopedic · 54d
Cleared Nov 12, 1997
ACE VALPROIC ACID REAGENT, AED CALIBRATORS
K973581 · LEG
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 12, 1997
ACE PRIMIDONE REAGENT, AED CALIBRATORS
K973582 · DJD
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 12, 1997
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
K973583 · KLS
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 12, 1997
ELECSYS FOLATE
K973674 · CDD
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Nov 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
K973850 · HFO
Alexander Mfg. Co.
Obstetrics & Gynecology · 35d
Cleared Nov 10, 1997
IMX CA 15-3
K964407 · MOI
Abbott Laboratories
Immunology · 371d
Cleared Nov 10, 1997
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
K965228 · MAI
United States Surgical, A Division of...
Orthopedic · 314d
Cleared Nov 10, 1997
APO-TEK LP(A)
K970302 · DFC
Perimmune, Inc.
Immunology · 287d
Cleared Nov 10, 1997
RAVEN DRY PRINTER
K972660 · LMC
Sterling Diagnostic Imaging, Inc.
Radiology · 117d
Cleared Nov 10, 1997
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
K972995 · JDI
Corin USA
Orthopedic · 90d
Cleared Nov 10, 1997
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
K972997 · IPF
Dan Med, Inc.
Physical Medicine · 90d
Cleared Nov 10, 1997
THE CORIFIX LIGAMENT ANCHOR
K973005 · HWC
Corin USA
Orthopedic · 89d
Cleared Nov 10, 1997
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009 · MBI
Mitek Products
Orthopedic · 89d
Cleared Nov 10, 1997
REALTIME 3D DIAGNOSTIC WORKSTATION
K973010 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 10, 1997
SYNTHES MINI LENGTHENING APPARATUS
K973018 · MQN
Synthes (Usa)
Dental · 89d
Cleared Nov 10, 1997
INTELECT LEGEND ULTRASOUND
K973024 · IMI
Chattanooga Group, Inc.
Physical Medicine · 88d
Cleared Nov 10, 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER...
K973113 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 82d
Cleared Nov 10, 1997
MAMMOTEST ADAPTER DRIVER
K973400 · IZH
Fischer Imaging Corp.
Radiology · 62d