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
99937–99960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1995
RESECTOSCOPES
K954050 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 85d
Cleared Nov 22, 1995
AUTO SUTURE* STERILIZATION TRAY**
K954090 · KCT
United States Surgical, A Division of...
General Hospital · 83d
Cleared Nov 22, 1995
SELECT IUI
K954099 · MFD
Select Medical Systems, Inc.
Obstetrics & Gynecology · 83d
Cleared Nov 22, 1995
HP ECHO IMAGE MANAGEMENT SYSTEM
K954668 · LLZ
Hewlett-Packard Co.
Radiology · 43d
Cleared Nov 22, 1995
BRONCHOSCOPE
K954707 · EOQ
Fujinon, Inc.
Ear, Nose, Throat · 41d
Cleared Nov 22, 1995
POCKETALKER PRO
K954748 · LZI
Williams Sound, LLC
Ear, Nose, Throat · 37d
Cleared Nov 21, 1995
LOW PROFILE CATHETER
K922567 · KNT
Rusch, Inc.
Gastroenterology & Urology · 1268d
Cleared Nov 21, 1995
FLOSCOPE SUPER VASCULAR LAB
K943200 · JAF
Advance Medical Device, Inc.
Radiology · 504d
Cleared Nov 21, 1995
SIEMENS Q4000
K945072 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 400d
Cleared Nov 21, 1995
INCLUSICE II(TM) ENDOSCOPE
K946087 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 343d
Cleared Nov 21, 1995
CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS
K946109 · KNS
Cabot Medical Corp.
Gastroenterology & Urology · 342d
Cleared Nov 21, 1995
MEDTRONIC GC IV CORONARY GUIDING CATHETER
K950490 · DQY
Medtronics Interventional Vascular
Cardiovascular · 288d
Cleared Nov 21, 1995
ATLAS ORTHOGONAL PERCUSSION INSTTUMENT
K951217 · LXM
Sweat Chiropractic Clinic
Physical Medicine · 249d
Cleared Nov 21, 1995
AMSET R-F SYSTEM
K951266 · MNH
Advanced Spine Technology, Inc.
Orthopedic · 245d
Cleared Nov 21, 1995
Z-WATCH SYSTEM
K951727 · IPF
Prizm Medical, Inc.
Physical Medicine · 222d
Cleared Nov 21, 1995
IMZ BONE TACK SYSTEM
K952167 · DZL
Interpore Intl.
Dental · 197d
Cleared Nov 21, 1995
EMC MODEL STATOME 200
K952231 · GEI
Emc Industries
General & Plastic Surgery · 193d
Cleared Nov 21, 1995
COAGUCHEK SYSTEM
K952625 · JPA
Boehringer Mannheim Corp.
Hematology · 166d
Cleared Nov 21, 1995
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
K952875 · CGA
Boehringer Mannheim Corp.
Chemistry · 155d
Cleared Nov 21, 1995
GENESIS
K953345 · JQW
Tecan U.S., Inc.
Chemistry · 132d
Cleared Nov 21, 1995
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
K953470 · HHD
Mediquip, Inc.
Obstetrics & Gynecology · 120d
Cleared Nov 21, 1995
IMPERIUM
K953905 · IQA
Teledyne Brown Engineering
Physical Medicine · 95d
Cleared Nov 21, 1995
DANTEC DA CAPO
K953999 · EXY
Dantec Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Nov 21, 1995
BECTON DICKINSON SYRINGSE
K954064 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 83d