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
77977–78000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2001
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
K011031 · MMW
Vysis
Immunology · 120d
Cleared Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · HWC
Aesculap, Inc.
Orthopedic · 114d
Cleared Aug 03, 2001
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
K011386 · MQV
Ebi, L.P.
Orthopedic · 88d
Cleared Aug 03, 2001
PERSYST REVEAL
K011397 · OMB
Persyst Development Corp.
Neurology · 88d
Cleared Aug 03, 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Aug 03, 2001
IN SPACE 3D
K011447 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Aug 03, 2001
MP-3C POWER BASE CHAIR, MODEL MP3C
K011687 · ITI
Merits Health Products., Inc.
Physical Medicine · 64d
Cleared Aug 03, 2001
SUPREMCAST
K011705 · EJH
American Dent-All, Inc.
Dental · 60d
Cleared Aug 03, 2001
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
K011707 · INI
Merits Medical Industries Co., Ltd.
Physical Medicine · 60d
Cleared Aug 03, 2001
FIRST FILL R.C.S.
K011748 · KIF
Jeneric/Pentron, Inc.
Dental · 58d
Cleared Aug 03, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
K011753 · INI
Merits Health Products., Inc.
Physical Medicine · 58d
Cleared Aug 03, 2001
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
K011768 · LSB
Thermo-Electric Co.
Physical Medicine · 57d
Cleared Aug 03, 2001
ADVANCED HIP ASSESSMENT SOFTWARE
K011917 · KGI
Ge Lunar Corp.
Radiology · 44d
Cleared Aug 03, 2001
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
K011971 · HAW
Image-Guided Neurologics, Inc.
Neurology · 39d
Cleared Aug 03, 2001
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS...
K012068 · MQE
Sims Portex , Ltd.
Obstetrics & Gynecology · 32d
Cleared Aug 03, 2001
NIDOIL
K012123 · MQL
Nidacon International AB
Obstetrics & Gynecology · 28d
Cleared Aug 03, 2001
1.5T INFINITY TWINSPEED MR SYSTEM
K012200 · LNH
GE Medical Systems
Radiology · 21d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · DKZ
Syva Co.
Chemistry · 16d
Cleared Aug 03, 2001
SOLARA JR. MANUAL WHEELCHAIR
K012370 · IOR
Invacare Corp.
Physical Medicine · 8d
Cleared Aug 02, 2001
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
K010413 · DQA
Konica Minolta Sensing, Inc.
Anesthesiology · 171d
Cleared Aug 02, 2001
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · KPO
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Aug 02, 2001
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
K011382 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 87d
Cleared Aug 02, 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · KTW
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 02, 2001
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 76d