FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cleared only ×
175,230 results
24073–24096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2018
Humeral Short Stem System
K173824 · MBF
Shoulder Innovations, Inc.
Orthopedic · 309d
Cleared Oct 23, 2018
Masimo Rad-97 and Accessories
K180046 · DQA
Masimo Corporation
Anesthesiology · 288d
Cleared Oct 23, 2018
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
K180622 · KNT
Covidien
Gastroenterology & Urology · 228d
Cleared Oct 23, 2018
JiveX
K181964 · LLZ
Visus Health IT GmbH
Radiology · 92d
Cleared Oct 23, 2018
Cumulus Remover
K182002 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 89d
Cleared Oct 23, 2018
Randox Calcium (Ca)
K182042 · CJY
Randox Laboratories, Ltd.
Chemistry · 85d
Cleared Oct 23, 2018
BTL 799-2T
K182106 · NGX
BTL Industries, Inc.
Physical Medicine · 81d
Cleared Oct 23, 2018
FUSE Pedicle Screw System
K182283 · NKB
Black Box Medical
Orthopedic · 61d
Cleared Oct 23, 2018
Xperius Ultrasound System
K182529 · IYN
Philips Ultrasound, Inc.
Radiology · 39d
Cleared Oct 23, 2018
GU60A, GU60A-65
K182622 · KPR
Samsung Electronics Co., Ltd.
Radiology · 29d
Cleared Oct 22, 2018
GM Implant Tubes, Length Cutting Gauge
K172533 · JAQ
Varian Medical Systems, Inc.
Radiology · 426d
Cleared Oct 22, 2018
TD-1035 Thermometer
K172733 · FLL
Taidoc Technology Corporation
General Hospital · 406d
Cleared Oct 22, 2018
ANTHEM Fracture System
K180554 · HRS
Globus Medical, Inc.
Orthopedic · 235d
Cleared Oct 22, 2018
PIP Fix
K181192 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 171d
Cleared Oct 22, 2018
Comarch e-Care Platform
K181248 · DRG
Comarch Healthcare SA
Cardiovascular · 165d
Cleared Oct 22, 2018
Quadra P
K181254 · LZO
Medacta International S.A.
Orthopedic · 164d
Cleared Oct 22, 2018
Nutrifill
K181566 · MRC
Contamac, Ltd.
Ophthalmic · 130d
Cleared Oct 22, 2018
Sonendo Material A
K181922 · KIF
Sonendo, Inc.
Dental · 96d
Cleared Oct 20, 2018
ImPACT
K181223 · POM
Impact Applications, Inc.
Neurology · 165d
Cleared Oct 19, 2018
Straumann cerabone
K173594 · NPM
Institut Straumann AG
Dental · 332d
Cleared Oct 19, 2018
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by...
K180202 · DBL
Immuno Concepts, N.A. , Ltd.
Immunology · 268d
Cleared Oct 19, 2018
AVELLE Negative Pressure Wound Therapy System
K180205 · OMP
Convatec Limited
General & Plastic Surgery · 268d
Cleared Oct 19, 2018
Titanium TomoFix Medial High Tibia Plate Anatomical
K180213 · HRS
Synthes USA Products, LLC
Orthopedic · 267d
Cleared Oct 19, 2018
EchoS
K180516 · MUA
Echolight S.P.A
Radiology · 234d