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
9073–9096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2023
Stat Profile Prime Plus Analyzer System
K221900 · CHL
Nova Biomedical Corporation
Chemistry · 456d
Cleared Sep 29, 2023
Antibacterial bandage
K221570 · FRO
Allmed Medical Products Co., Ltd.
General & Plastic Surgery · 486d
Cleared Sep 29, 2023
AnemoCheck Home
K221508 · KHG
Sanguina, Inc.
Hematology · 493d
Cleared Sep 29, 2023
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2...
K221359 · JPA
Instrumentation Laboratory CO
Hematology · 506d
Cleared Sep 29, 2023
StarFormer, TightWave
K221274 · IPF
Fotona D.O.O.
Physical Medicine · 515d
Cleared Sep 29, 2023
UltraFlo-R Push Button Blood Collection Set
K220458 · JKA
Innovative Medical Technologies, Inc.
General Hospital · 589d
Cleared Sep 29, 2023
Aptiva CTD Essential Reagent
K213403 · LLL
Inova Diagnostics, Inc.
Immunology · 711d
Cleared Sep 29, 2023
DYNEX SmartPLEX MMRV IgG Assay Kit
K212769 · OPL
Dynex Technologies, Inc.
Microbiology · 759d
Cleared Sep 28, 2023
BeautiLink SA
K233161 · EMA
Shofu Dental Corporation
Dental · 1d
Cleared Sep 28, 2023
Low Ejection Fraction AI-ECG Algorithm
K232699 · QYE
Anumana, Inc.
Cardiovascular · 23d
Cleared Sep 28, 2023
Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion...
K232605 · OUR
Lesspine Innovations
Orthopedic · 31d
Cleared Sep 28, 2023
IPL hair removal device
K232274 · OHT
Lumenessa Corp
General & Plastic Surgery · 59d
Cleared Sep 28, 2023
Hakon, Hakon Smart
K231901 · GEX
Medical San Ind?stria DE Equipamentos...
General & Plastic Surgery · 92d
Cleared Sep 28, 2023
Brainomix 360 Triage LVO
K231837 · QAS
Brainomix Limited
Radiology · 98d
Cleared Sep 28, 2023
VeriSafe Safety sterile syringes
K231792 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 100d
Cleared Sep 28, 2023
ALIGN Radial Head System
K231188 · KWI
Skeletal Dynamics, Inc.
Orthopedic · 155d
Cleared Sep 28, 2023
DNA/RNA Shield SafeCollect Saliva Collection kit
K231013 · QBD
Zymo Research
Microbiology · 171d
Cleared Sep 28, 2023
PIVO™ Pro Needle-free Blood Collection Device
K230865 · JKA
Becton Dickinson Infusion Therapy...
General Hospital · 183d
Cleared Sep 27, 2023
Cove Strip, OsteoCove Strip
K232668 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 26d
Cleared Sep 27, 2023
Volta AF-Xplorer
K232616 · DQK
Volta Medical
Cardiovascular · 30d
Cleared Sep 27, 2023
Micro Ace™ Advanced Micro Access System
K232609 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Sep 27, 2023
EndoGI S-Path Biliary Stent System
K232596 · FGE
Endogi Medical, Ltd.
Gastroenterology & Urology · 33d
Cleared Sep 27, 2023
Invictus® Spinal Fixation System
K232275 · NKB
Alphatec Spine, Inc.
Orthopedic · 58d
Cleared Sep 27, 2023
Thinline Sheath Introducer
K232260 · DYB
Inneuroco, Inc.
Cardiovascular · 58d