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
7849–7872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2024
Access CK-MB
K234005 · JHX
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Feb 16, 2024
S-Patch (S-Patch ExL)
K233906 · DSH
Wellysis Corp.
Cardiovascular · 66d
Cleared Feb 16, 2024
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
K233708 · DYB
Synaptic Medical Corporation
Cardiovascular · 88d
Cleared Feb 16, 2024
Biowy Tym Tube (TT)
K233658 · ETD
Biowy Corporation
Ear, Nose, Throat · 93d
Cleared Feb 16, 2024
Contour Hand/Wrist (Q7000232)
K233652 · MOS
Quality Electrodynamics
Radiology · 94d
Cleared Feb 16, 2024
Montage Flowable Settable, Resorbable Bone Paste
K232771 · GXP
Orthocon, Inc.
Neurology · 158d
Cleared Feb 16, 2024
Airgle Room Air Purifier
K232645 · FRA
Airgle Corporation
General Hospital · 170d
Cleared Feb 16, 2024
Zenition 30
K232420 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 189d
Cleared Feb 16, 2024
Dental LT Comfort Resin
K232087 · MQC
Formlabs Ohio, Inc.
Dental · 218d
Cleared Feb 16, 2024
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B,...
K232043 · FDF
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 221d
Cleared Feb 16, 2024
Disposable Grounding Pad
K231985 · GEI
Shenzhen Mecun Medical Supply Co., Ltd.
General & Plastic Surgery · 226d
Cleared Feb 16, 2024
AGILON® XO Shoulder Replacement System
K231657 · KWT
Implantcast GmbH
Orthopedic · 254d
Cleared Feb 16, 2024
Oral Matrix
K231513 · NPL
Beijing Biosis Healing Biolog Ical...
Dental · 267d
Cleared Feb 16, 2024
SnapHammer Hammertoe Correction System
K231453 · HWC
Nvision Biomedical Technologies, Inc.
Orthopedic · 274d
Cleared Feb 16, 2024
Medline Luer Lock Syringes
K230235 · FMF
Medline Industries, LP
General Hospital · 385d
Cleared Feb 15, 2024
InVision™ 1.5 Surgical Theatre
K240157 · LNH
Deerfield Imaging, Inc.
Radiology · 27d
Cleared Feb 15, 2024
Medical Monitor (21HQ613D)
K240130 · PGY
Lg Electronics.Inc
Radiology · 29d
Cleared Feb 15, 2024
SONIK MONARK 100
K234036 · LXM
Neuro Spinal Innovation, Inc.
Physical Medicine · 56d
Cleared Feb 15, 2024
COPAL® exchange G hip spacer
K234028 · KWL
Heraeus Medical GmbH
Orthopedic · 57d
Cleared Feb 15, 2024
Contour Shoulder
K233656 · MOS
Quality Electrodynamics
Radiology · 93d
Cleared Feb 15, 2024
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere...
K233483 · MCW
Cardio Flow Inc.,
Cardiovascular · 111d
Cleared Feb 15, 2024
EpiMonitor
K232915 · POS
Empatica S.R.L.
Neurology · 149d
Cleared Feb 15, 2024
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
K232245 · FGE
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 202d
Cleared Feb 15, 2024
MS55 Plus Digital Color Doppler Ultrasound System (MS55)
K231659 · IYN
Medisono
Radiology · 253d