FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
22633–22656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Jul 08, 2019
ProVate Vaginal Support
K190277 · HHW
Contipi Medical , Ltd.
Obstetrics & Gynecology · 150d
Cleared Jul 08, 2019
Materialise Glenoid Positioning System
K190286 · KWS
Materialise NV
Orthopedic · 147d
Cleared Jul 08, 2019
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K190485 · JKA
Kawasumi Laboratories, Inc.
General Hospital · 131d
Cleared Jul 08, 2019
RayCare 2.3
K191384 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 46d
Cleared Jul 08, 2019
BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
K191580 · JAQ
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jul 05, 2019
Aesculap® SterilContainer(TM) S2 System
K182414 · KCT
Aesculap, Inc.
General Hospital · 304d
Cleared Jul 05, 2019
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
K182901 · JAK
Canon Medical Systems Corporation
Radiology · 262d
Cleared Jul 05, 2019
syngo.MR Applications
K182904 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 262d
Cleared Jul 05, 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K190174 · JXG
Aesculap, Inc.
Neurology · 154d
Cleared Jul 05, 2019
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face...
K190254 · BZD
Sleepnet Corporation
Anesthesiology · 148d
Cleared Jul 05, 2019
OrthoPediatrics Cannulated Screw System
K190324 · HWC
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared Jul 05, 2019
BTL 799-2L
K190456 · NGX
BTL Industries, Inc.
Physical Medicine · 130d
Cleared Jul 05, 2019
Fortilink® IBF System with TETRAfuse®3D Technology, include the following...
K190498 · MAX
Pioneer Surgical Technology, Inc....
Orthopedic · 127d
Cleared Jul 05, 2019
BIOMONITOR III, Remote Assistant III
K190548 · MXD
Biotronik, Inc.
Cardiovascular · 122d
Cleared Jul 05, 2019
AngioVac C20, AngioVac C180
K190594 · DWF
AngioDynamics, Inc.
Cardiovascular · 120d
Cleared Jul 05, 2019
Arthrex NanoScope System
K190645 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 114d
Cleared Jul 05, 2019
Revitive Medic Plus, Revitive Advanced 2
K190924 · NGX
Actegy , Ltd.
Physical Medicine · 87d
Cleared Jul 05, 2019
Zimmer Guide Wire Devices
K191238 · HSB
Zimmer, Inc.
Orthopedic · 58d
Cleared Jul 05, 2019
Harrier-SA Lumbar Interbody System
K191367 · MAX
Choice Spine, LLC
Orthopedic · 44d
Cleared Jul 04, 2019
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with...
K183149 · LZC
Central Medicare Sdn Bhd
General Hospital · 233d
Cleared Jul 04, 2019
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3...
K190950 · FYA
Medline Industries, Inc.
General Hospital · 84d
Cleared Jul 03, 2019
AlphaDent Implants Dental Implants System
K180968 · DZE
Alphadent Implants, Ltd.
Dental · 446d
Cleared Jul 03, 2019
Novidia Flowable Composite
K182580 · EBF
Nobio , Ltd.
Dental · 287d
Cleared Jul 03, 2019
XP Composite
K182780 · EBF
S&C Polymer Silicon- Und Composite...
Dental · 275d