FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
4033–4056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2025
AllTest Multi-Drug Rapid Urine Test Cup
K250727 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 24d
Cleared Apr 04, 2025
Passeo-35 Xeo Peripheral Dilatation Catheter
K250706 · LIT
Biotronik, Inc.
Cardiovascular · 25d
Cleared Apr 04, 2025
DeGen Medical Patient Specific Implant (PSI) System
K250667 · MAX
Degen Medical
Orthopedic · 30d
Cleared Apr 04, 2025
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
K250656 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 30d
Cleared Apr 04, 2025
Virage® OCT Spinal Fixation System
K250332 · NKG
Highridge Medical, LLC
Orthopedic · 58d
Cleared Apr 04, 2025
Turbett Surgical Instrument Pod (TS1500)
K250011 · FRG
Turbett Surgical
General Hospital · 92d
Cleared Apr 04, 2025
Bicarby Dialysate RFP-402 (RFP-402-G)
K243786 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 116d
Cleared Apr 04, 2025
QFR (3.0)
K243769 · QHA
Qfr Solutions BV
Radiology · 119d
Cleared Apr 04, 2025
LiquID .051 LP Guide Catheter Extension
K243691 · DQY
Seigla Medical, Inc.
Cardiovascular · 129d
Cleared Apr 04, 2025
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
K243581 · FMI
Terumo Europe N.V.
General Hospital · 141d
Cleared Apr 04, 2025
JETi Hydrodynamic Thrombectomy System
K243549 · QEZ
Abbott Medical
Cardiovascular · 140d
Cleared Apr 04, 2025
WHOOP ECG (electrocardiogram) Feature (1.0)
K243236 · QDA
Whoop., Inc.
Cardiovascular · 176d
Cleared Apr 04, 2025
Spectrum Spine Lumbar Cage System
K243074 · MAX
Spectrum Spine, Inc.
Orthopedic · 189d
Cleared Apr 04, 2025
HeartFocus (V.1.1.1)
K242807 · QJU
Deski
Radiology · 199d
Cleared Apr 04, 2025
VentStar Resus heated (N) (MP17030)
K242769 · BTL
Draegerwerk AG & CO Kgaa
Anesthesiology · 203d
Cleared Apr 04, 2025
AllTest Viral Transport Medium
K242576 · JSM
Hangzhou AllTest Biotech Co., Ltd.
Microbiology · 218d
Cleared Apr 04, 2025
UASure II Blood Uric Acid Monitoring System
K242209 · PTC
Apex BioTechnology Corp.
Chemistry · 249d
Cleared Apr 04, 2025
EyeBOX EBX-4.1
K242116 · QEA
Oculogica, Inc.
Neurology · 259d
Cleared Apr 04, 2025
TRIOS Ready Tip
K242103 · NBL
3Shape TRIOS A/S
Dental · 260d
Cleared Apr 04, 2025
LED Light Therapy Mask (RT01)
K242068 · OLP
Ningbo Dechang Electrical Machinery...
General & Plastic Surgery · 263d
Cleared Apr 04, 2025
Philips VSC-MEDlib
K242001 · BZQ
Philips Medical Systems Nederland B.V.
Anesthesiology · 269d
Cleared Apr 04, 2025
DeepFoqus (DeepFoqus-Accelerate)
K241982 · QIH
Foqus Technologies, Inc.
Radiology · 273d
Cleared Apr 04, 2025
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation...
K240398 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 420d
Cleared Apr 03, 2025
SureFine Pen Needle
K250658 · FMI
Shina Med Corporation
General Hospital · 29d