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
6937–6960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2024
ShockPhysio Mobile (model SW3200 Basic)
K240358 · ISA
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 120d
Cleared Jun 05, 2024
VELYS Robotic-Assisted Solution
K240211 · OLO
Depuy Ireland UC
Orthopedic · 132d
Cleared Jun 05, 2024
Tapered Pro Conical Implant System
K240187 · DZE
BioHorizons Implant Systems, Inc.
Dental · 133d
Cleared Jun 05, 2024
Mobility Scooter (W3331)
K240008 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 155d
Cleared Jun 05, 2024
Cannulated Headless Bone Screws
K233008 · HWC
Aap Implantate AG
Orthopedic · 257d
Cleared Jun 04, 2024
Ingenix Spinal System
K241258 · NKB
Ingenium Spine
Orthopedic · 29d
Cleared Jun 04, 2024
Monteris Medical NeuroBlate System
K240877 · ONO
Monteris Medical,
Neurology · 67d
Cleared Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
K240627 · PEO
Luminex Corporation
Microbiology · 90d
Cleared Jun 04, 2024
Eminent Spine SI Screw System
K240505 · OUR
Eminent Spine, LLC
Orthopedic · 104d
Cleared Jun 04, 2024
Slow Wave DS8 (SWDS802)
K240463 · MQC
Slow Wave, Inc.
Dental · 109d
Cleared Jun 04, 2024
Dermalux Tri-Wave MD MKII (1000021)
K240222 · GEX
Aesthetic Technology, Ltd.
General & Plastic Surgery · 130d
Cleared Jun 04, 2024
SAM Model 9-10000
K240100 · MNR
Snap Diagnostics, LLC
Anesthesiology · 144d
Cleared Jun 04, 2024
Hudson RCI Dri-Tech Breathing Circuits
K234032 · BZE
Medline Industries, LP
Anesthesiology · 167d
Cleared Jun 04, 2024
Arthrex AlloSync PushLock Suture Anchor
K233971 · MAI
Arthrex, Inc.
Orthopedic · 172d
Cleared Jun 04, 2024
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
K232820 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 265d
Cleared Jun 04, 2024
da Vinci SP Surgical System (SP1098)
K232773 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 267d
Cleared Jun 03, 2024
Amplatz Goose Neck Snare Kit
K241259 · MMX
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jun 03, 2024
TENSOR® Suture Button System
K240947 · HTN
Globus Medical, Inc.
Orthopedic · 56d
Cleared Jun 03, 2024
EcoFit® short stem cementless cpTi
K240834 · LZO
Implantcast GmbH
Orthopedic · 69d
Cleared Jun 03, 2024
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K240617 · PKL
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared Jun 03, 2024
Maestro System (REF100)
K240598 · FQO
Moon Surgical
General & Plastic Surgery · 91d
Cleared Jun 03, 2024
ANNE Chest
K240251 · DRG
Sibel Health, Inc.
Cardiovascular · 125d
Cleared Jun 03, 2024
Milieve (YPS-301BD)
K233751 · PCC
Soterix Medical, Inc.
Neurology · 194d
Cleared Jun 03, 2024
LOCATOR Angled Abutment (Various)
K233587 · NHA
Zest Anchors, LLC
Dental · 208d