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
11737–11760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2022
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
K222124 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 109d
Cleared Nov 04, 2022
Self-adhesive Electrode
K222453 · GXY
Guangdong Comytens Medical Technology...
Neurology · 81d
Cleared Nov 04, 2022
VHA Radiotherapy Bolus
K222639 · IXI
Vha Dean
Radiology · 64d
Cleared Nov 04, 2022
Disposable Medical Face Mask (DF3-001)
K222697 · FXX
Wellmed Dental Medical Supply Co., Ltd.
General Hospital · 58d
Cleared Nov 04, 2022
World Total Knee System
K223062 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 35d
Cleared Nov 04, 2022
Aquilo Sports CCT1500 System
K223164 · IRP
Aquilo Sports, LLC
Neurology · 28d
Cleared Nov 03, 2022
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes,...
K220263 · HQB
Vortex Surgical, Inc.
Ophthalmic · 276d
Cleared Nov 03, 2022
ibiomedi Electronic Stethoscope ES-2020
K220466 · DQD
Sound Land Corp.
Cardiovascular · 259d
Cleared Nov 03, 2022
Insulin Syringes without needle
K221045 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 209d
Cleared Nov 03, 2022
NP Medical nCompass Extension Set with Stabilizing Base
K221518 · FPA
Np Medical
General Hospital · 162d
Cleared Nov 03, 2022
ABTross ALIF Expandable Cage System
K221719 · MAX
Aegis Spine, Inc.
Orthopedic · 143d
Cleared Nov 03, 2022
Black Diamond™ POCT Spinal System
K222107 · NKG
Osseus Fusion Systems
Orthopedic · 108d
Cleared Nov 03, 2022
Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie...
K222168 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 105d
Cleared Nov 03, 2022
Led Mask Platinum Md
K222377 · OHS
Cellreturn Co., Ltd.
General & Plastic Surgery · 90d
Cleared Nov 03, 2022
truSculpt iD
K223110 · GEI
Cutera, Inc.
General & Plastic Surgery · 31d
Cleared Nov 03, 2022
Tera Harz Clear
K223355 · NXC
Graphy, Inc.
Dental · 1d
Cleared Nov 02, 2022
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for...
K211816 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 509d
Cleared Nov 02, 2022
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded...
K220371 · LZA
Summit Glove, Inc.
General Hospital · 266d
Cleared Nov 02, 2022
ORiGO System
K221184 · ERL
Bien-Air Surgery SA
Ear, Nose, Throat · 191d
Cleared Nov 02, 2022
OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance...
K222084 · FMK
Asahi Polyslider Co., Ltd.
General & Plastic Surgery · 110d
Cleared Nov 02, 2022
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
K222395 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 86d
Cleared Nov 02, 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K223320 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 5d
Cleared Nov 01, 2022
Back 3 COLOR
K214090 · PBX
Swims America Corp
General & Plastic Surgery · 308d
Cleared Nov 01, 2022
Klarity SRS Baseplate, Klarity Promise Baseplate
K220539 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 249d