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
12217–12240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2022
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
K222537 · OHT
Shenzhen Ishine Technology Company...
General & Plastic Surgery · 53d
Cleared Oct 14, 2022
Vitrea CT Cardiac Analysis
K222662 · LLZ
Canon Medical Informatics, Inc.
Radiology · 42d
Cleared Oct 14, 2022
X-Pac Expandable Lumbar Cage System
K222797 · MAX
Expanding Innovations, Inc.
Orthopedic · 28d
Cleared Oct 13, 2022
Wireless Probe Type Ultrasound Scanner (Model: CProbe
K211321 · IYN
Guangzhou Sonostar Technologies Co.,...
Radiology · 531d
Cleared Oct 13, 2022
CREOKORREKT Aligners
K211427 · NXC
Creodent Prosthetics, Ltd.
Dental · 524d
Cleared Oct 13, 2022
IM/ST Fixture System
K212702 · DZE
Guilin Fiteeth Medical Instrument...
Dental · 413d
Cleared Oct 13, 2022
SPIFE A1AT kit
K213396 · OBZ
Helena Laboratories, Corp.
Immunology · 360d
Cleared Oct 13, 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730 · KOD
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 213d
Cleared Oct 13, 2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805 · LON
bioMerieux, Inc.
Microbiology · 209d
Cleared Oct 13, 2022
PicoWay Laser System
K220853 · GEX
Candela Corporation
General & Plastic Surgery · 204d
Cleared Oct 13, 2022
X-CUBE 50, X-CUBE 60
K220857 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 204d
Cleared Oct 13, 2022
Fiber Laser Treatment System
K221770 · ONG
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 114d
Cleared Oct 13, 2022
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer,...
K221857 · DXQ
Zhejiang Lude Technology Development...
Cardiovascular · 108d
Cleared Oct 13, 2022
The Oligio
K221989 · GEI
Wontech Co., Ltd.
General & Plastic Surgery · 99d
Cleared Oct 13, 2022
ID-510 iRestore Elite
K222081 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 90d
Cleared Oct 13, 2022
SCIg60 Infusion System
K222087 · PKP
Emed Technologies Corporation
General Hospital · 90d
Cleared Oct 13, 2022
Abiomed 14Fr Low Profile Introducer Set
K222113 · DYB
Abiomed, Inc.
Cardiovascular · 87d
Cleared Oct 13, 2022
UNITY Sacroiliac Joint Fixation System
K222448 · OUR
Dio Medical Corporation
Orthopedic · 59d
Cleared Oct 13, 2022
EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
K222473 · NKB
Medos International SARL
Orthopedic · 58d
Cleared Oct 13, 2022
Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
K222763 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 30d
Cleared Oct 12, 2022
AT-Patch ECG Analysis System
K203638 · DSH
Atsens Co., Ltd.
Cardiovascular · 667d
Cleared Oct 12, 2022
PiezoImplant System
K211872 · NRQ
Rex Implants, Inc.
Dental · 482d
Cleared Oct 12, 2022
OW100S (model OW100S-US)
K213120 · ISA
Tissue Regeneration Technologies, LLC...
Physical Medicine · 380d
Cleared Oct 12, 2022
MOST-T Autoclave
K220102 · FLE
Shinva Medical Instrument Co., Ltd.
General Hospital · 273d