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
5089–5112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · MMI
Abbott Point of Care, Inc.
Chemistry · 268d
Cleared Jan 03, 2025
NobelProcera Zirconia Implant Bridge
K240346 · NHA
Nobel Biocare AB
Dental · 333d
Cleared Jan 03, 2025
GBR System
K233419 · DZL
Proimtech Saglik Urunleri Anonim Sirketi
Dental · 451d
Cleared Jan 03, 2025
DUET-V (Model: ESK-3261DV)
K233118 · GEI
Eunsung Global Corp
General & Plastic Surgery · 464d
Cleared Jan 02, 2025
Pulse Oximeter (FS20P)
K243049 · DQA
Hunan Accurate Bio-Medical Technology...
Anesthesiology · 97d
Cleared Jan 02, 2025
Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
K242789 · OHS
Dongguan Laiguang Electronic...
General & Plastic Surgery · 108d
Cleared Jan 02, 2025
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
K242448 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 139d
Cleared Jan 02, 2025
Ezra Flash
K242334 · QIH
Ezra Ai, Inc.
Radiology · 148d
Cleared Jan 02, 2025
Wave Electrode (AE02-60)
K242326 · GXY
Bionit Labs Srl
Neurology · 149d
Cleared Jan 02, 2025
Ortho AI
K241696 · QIH
Ortho Ai, LLC
Radiology · 204d
Cleared Jan 02, 2025
CrystLCare™ PRO Biorestorative, Fluoride-Plus
K241568 · LBH
GreenMark Biomedical, Inc.
Dental · 216d
Cleared Jan 02, 2025
Rist 079 Radial Access Guide Catheter
K241388 · QJP
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 232d
Cleared Jan 02, 2025
Haemostasis Clips
K241005 · PKL
Jiangxi Zhuoruihua Medical Instrument...
Gastroenterology & Urology · 265d
Cleared Dec 31, 2024
Idys® LIF
K243670 · MAX
Clariance
Orthopedic · 34d
Cleared Dec 31, 2024
Nasal Pillow Mask - Small (NNPM-01/ Nefes S)
K243225 · BZD
Genadyne Biotechnologies, Inc.
Anesthesiology · 84d
Cleared Dec 31, 2024
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
K243224 · DQY
Abbott Medical
Cardiovascular · 85d
Cleared Dec 31, 2024
Electric Wheelchair (MODEL H)
K242989 · ITI
Nanjing E-Take Medical Apparatus Co.,...
Physical Medicine · 96d
Cleared Dec 31, 2024
Power Wheelchair (D10, D12, D15, D17, D20, D37)
K242468 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 133d
Cleared Dec 31, 2024
Nasal Aspirator (NS 13)
K241852 · BTA
Avita Corporation
Ear, Nose, Throat · 187d
Cleared Dec 31, 2024
Peak Flow Meter
K241338 · BZH
Chongqing Moffy Innovation Technology...
Anesthesiology · 232d
Cleared Dec 30, 2024
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
K243445 · GEX
Bios S.R.L.
General & Plastic Surgery · 54d
Cleared Dec 30, 2024
AF531 Oro-Nasal SE Face Mask
K243394 · CBK
Respironics, Inc.
Anesthesiology · 60d
Cleared Dec 30, 2024
PAL Aspiration System
K242804 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 104d
Cleared Dec 30, 2024
Next Generation Access Platform
K242376 · QJP
Balt USA, LLC
Neurology · 143d