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

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175,820 results
24361–24384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2018
Konicaminolta DI-X1
K182431 · LLZ
Konica Minolta, Inc.
Radiology · 81d
Cleared Nov 26, 2018
Plateau Spacer System
K182470 · MAX
Life Spine
Orthopedic · 77d
Cleared Nov 26, 2018
Selethru PTCA Balloon Dilatation Catheter
K182699 · LOX
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 60d
Cleared Nov 26, 2018
HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE...
K183009 · GEI
Hemostatix Medical Technologies, LLC
General & Plastic Surgery · 26d
Cleared Nov 26, 2018
Vitrea Software Package, VSTP-001A
K183013 · LLZ
Canon Medical Systems Corporation
Radiology · 26d
Cleared Nov 26, 2018
Corin Optimized Positioning System (OPS) Plan
K183038 · LLZ
Corin USA
Radiology · 25d
Cleared Nov 26, 2018
3M Clarity Aligners
K183159 · NXC
3M Company
Dental · 11d
Cleared Nov 26, 2018
FlexCath Advance Steerable Sheath and Dilator
K183174 · DRA
Medtronic Cryocath, LP
Cardiovascular · 10d
Cleared Nov 23, 2018
Digistat Smart Central
K180430 · MSX
Ascom Ums Srl Unipersonale
Cardiovascular · 280d
Cleared Nov 23, 2018
Greene Renal Transplant Stent Set
K180557 · FAD
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Nov 23, 2018
Responsive Arthroscopy Interference Screw System
K180573 · HWC
Responsive Arthroscopy, LLC
Orthopedic · 263d
Cleared Nov 23, 2018
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
K180607 · PCG
Kronus, Inc.
Immunology · 261d
Cleared Nov 23, 2018
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
K180643 · FRO
Medcu Technologies , Ltd.
General & Plastic Surgery · 256d
Cleared Nov 23, 2018
A.B. Dental Devices Dental Implants System
K181381 · NHA
A.B. Dental Device , Ltd.
Dental · 183d
Cleared Nov 23, 2018
Accula RSV Test
K181443 · OCC
Mesa Biotech, Inc.
Microbiology · 176d
Cleared Nov 23, 2018
Hyper GP (tisilfocon A) Daily Wear Contact Lens
K182304 · HQD
Contamac, Ltd.
Ophthalmic · 91d
Cleared Nov 23, 2018
HammerTechTM Fixation System
K182684 · HWC
Fusion Orthopedics, LLC
Orthopedic · 58d
Cleared Nov 23, 2018
Motion Tracking and Compensation Feature for the Radixact Treatment Delivery...
K182687 · IYE
Accuray Incorporated
Radiology · 58d
Cleared Nov 23, 2018
Visor System
K182967 · QAF
Cerebrotech Medical Systems, Inc.
Neurology · 28d
Cleared Nov 22, 2018
Sunkingdom Slit Lamp
K182306 · HJO
Chongqing Sunkingdom Medical...
Ophthalmic · 90d
Cleared Nov 21, 2018
ProFuse CAD
K173744 · LLZ
Eigen
Radiology · 349d
Cleared Nov 21, 2018
DePuy Synthes 2.0 mm Quick Insertion Screws
K180541 · HWC
Synthes USA Products, LLC
Orthopedic · 265d
Cleared Nov 21, 2018
Jet Power Injectable PICC
K180546 · LJS
Jet Medical, Inc.
General Hospital · 265d
Cleared Nov 21, 2018
ApnoDent Appliance
K181123 · LRK
Apnomed, Inc.
Dental · 205d