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
5761–5784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2024
IceSeed 1.5 CX Straight Needle (H7493968333170)
K243245 · GEH
Boston Scientific Corp
General & Plastic Surgery · 7d
Cleared Oct 18, 2024
dS Wrist coil 8ch 1.5T
K243033 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 21d
Cleared Oct 18, 2024
dS Knee Coil 8ch 1.5T
K242879 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 25d
Cleared Oct 18, 2024
Kinos Total Ankle System
K242868 · HSN
Restor3d
Orthopedic · 28d
Cleared Oct 18, 2024
ROSA® Knee System
K242864 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 28d
Cleared Oct 18, 2024
BriefCase-Triage
K242837 · QAS
Aidoc Medical , Ltd.
Radiology · 29d
Cleared Oct 18, 2024
Corplex P/ Theracor P/ Allacor P
K242828 · KGN
Stimlabs, LLC
General & Plastic Surgery · 29d
Cleared Oct 18, 2024
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K242813 · QHE
Materialise NV
Orthopedic · 30d
Cleared Oct 18, 2024
Altis Single Incision Sling System (519650)
K242473 · PAH
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Oct 18, 2024
Dental Barrier and Sleeves
K242435 · PEM
Wellmed Dental Medical Supply Co., Ltd.
Dental · 63d
Cleared Oct 18, 2024
Mg OSTEOREVIVE™, Mg OSTEOCRETE™
K242372 · MQV
Bone Solutions, Inc.
Orthopedic · 70d
Cleared Oct 18, 2024
FREDDO
K242132 · GEX
Fabinject Lndustria E Comercio...
General & Plastic Surgery · 88d
Cleared Oct 18, 2024
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD)
K241959 · FRC
3M Company
General Hospital · 107d
Cleared Oct 18, 2024
Mojo Full Face Vented Mask
K241830 · BZD
Sleepnet Corporation
Anesthesiology · 116d
Cleared Oct 18, 2024
Contour+ (MVision AI Segmentation)
K241490 · QKB
Mvision AI OY
Radiology · 147d
Cleared Oct 18, 2024
edelweiss CAD/CAM T-BLOCK
K241131 · EBF
Edelweiss Dentistry Products GmbH
Dental · 177d
Cleared Oct 18, 2024
Surgical Face Mask (Tie on/ Ear loops)
K240916 · FXX
Xiantao Daoqi Plastic Co., Ltd.
General Hospital · 198d
Cleared Oct 18, 2024
Spectral CT 7500 RT
K240844 · JAK
Philips Medical Systems Technologies...
Radiology · 205d
Cleared Oct 18, 2024
PreXolid CAD/CAM abutments
K240725 · NHA
Eclectic Co., Ltd.
Dental · 214d
Cleared Oct 18, 2024
Pixie Skin Tag
K240226 · ORE
Oystershell NV
General & Plastic Surgery · 266d
Cleared Oct 18, 2024
ABCcolla® Collagen ADM Scaffold
K233378 · KGN
Acro Biomedical Co., Ltd.
General & Plastic Surgery · 382d
Cleared Oct 18, 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
K233054 · NUH
Well-Life Healthcare Limited
Neurology · 389d
Cleared Oct 18, 2024
Vittra APS Unique Flow
K232994 · EBF
Dentscare Ltda
Dental · 392d
Cleared Oct 18, 2024
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide...
K222944 · GAP
Safepath Medical, Inc.
General & Plastic Surgery · 753d