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
673–696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2026
OxyGo Portable Oxygen Concentrator (1400-7000)
K252407 · CAW
Mv Life, LLC
Anesthesiology · 266d
Cleared Apr 23, 2026
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
K252389 · DSH
Smwmed, Inc.
Cardiovascular · 266d
Cleared Apr 23, 2026
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
K252341 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Apr 22, 2026
corra™ cervical plating system
K260570 · KWQ
Carlsmed, Inc.
Orthopedic · 62d
Cleared Apr 22, 2026
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
K260239 · HGX
Jiangxi AOV Maternity & Baby Products...
Obstetrics & Gynecology · 86d
Cleared Apr 22, 2026
Mobility Scooter (X-12, X-14, X-17)
K260237 · INI
Wuyi Aichi Industry and Trade Co., Ltd.
Physical Medicine · 86d
Cleared Apr 22, 2026
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
K260150 · OHS
NOOANCE
General & Plastic Surgery · 92d
Cleared Apr 22, 2026
VANISH PRO
K253765 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 148d
Cleared Apr 22, 2026
myosmart. (13E522)
K253256 · GXY
Otto Bock Healthcare Products GmbH
Neurology · 205d
Cleared Apr 22, 2026
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit
K253230 · GEH
Erbe Elektromedizin GmbH
General & Plastic Surgery · 205d
Cleared Apr 22, 2026
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K253163 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 208d
Cleared Apr 22, 2026
uOmnispace.MR
K253077 · QIH
Shanghai United Imaging Healthcare...
Radiology · 211d
Cleared Apr 22, 2026
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM...
K252306 · QVB
Steritec Products
General Hospital · 272d
Cleared Apr 21, 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · MBI
Tigon Medical
Orthopedic · 33d
Cleared Apr 21, 2026
EvoEndo Single-Use Endoscopy System
K260573 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 60d
Cleared Apr 21, 2026
IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371,...
K260518 · OHT
Shenzhen Semlamp Intelligent...
General & Plastic Surgery · 63d
Cleared Apr 21, 2026
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
K260447 · JWY
Biom?rieux SA
Microbiology · 69d
Cleared Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Apr 21, 2026
BosCATH Support Catheter
K254046 · QJP
Sonorous NV, Inc.
Neurology · 125d
Cleared Apr 21, 2026
Korotkoff sound blood pressure monitor
K253982 · DXN
Beijing Hanvon Health Technology Co.,...
Cardiovascular · 130d
Cleared Apr 21, 2026
RhythmStar System (SL)
K250793 · QYX
RhythMedix, LLC
Cardiovascular · 403d
Cleared Apr 20, 2026
EnSite™ X EP System
K260212 · DQK
Abbott Medical
Cardiovascular · 87d
Cleared Apr 20, 2026
Q-Switched Nd: YAG Laser System (Glamor Q)
K260153 · GEX
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 90d
Cleared Apr 20, 2026
Power Wheelchair (N5919 series)
K253806 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 143d