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
4465–4488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2025
Vent Creativity Knee v1.0 (Hermes)
K241961 · QIH
Vent Creativity
Radiology · 260d
Cleared Mar 20, 2025
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
K241884 · LPL
Hunan Haipuming Technology Co., Ltd.
Ophthalmic · 265d
Cleared Mar 20, 2025
Endoscopic Water Pump
K241704 · OCX
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 280d
Cleared Mar 19, 2025
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series...
K250502 · LZA
Safesource Direct, LLC
General Hospital · 27d
Cleared Mar 19, 2025
DSPS-Prominent® baseplate, MR (113820)
K250429 · IYE
Macromedics BV
Radiology · 33d
Cleared Mar 19, 2025
Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B,...
K250210 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 54d
Cleared Mar 19, 2025
IPL Hair Removal Device (BE965A, BE965B, BE965C)
K250171 · OHT
Shenzhen Yang WO Electronic Co., Ltd.
General & Plastic Surgery · 57d
Cleared Mar 19, 2025
IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023,...
K250131 · OHT
Mustech Electronics Co., Limited
General & Plastic Surgery · 61d
Cleared Mar 19, 2025
PeekMed web
K250042 · QIH
Peek Health, S.A.
Radiology · 70d
Cleared Mar 19, 2025
TriMed Ankle Fixation System
K243999 · HRS
TriMed, Inc.
Orthopedic · 83d
Cleared Mar 19, 2025
TriMed Elbow and Forearm System
K243987 · HRS
TriMed, Inc.
Orthopedic · 86d
Cleared Mar 19, 2025
AVIEW
K243689 · QIH
Coreline Soft Co., Ltd.
Radiology · 110d
Cleared Mar 19, 2025
1NEED Pro
K243472 · QAI
Campomats S.R.L.
General & Plastic Surgery · 131d
Cleared Mar 19, 2025
EXPD 4343N1
K243443 · MQB
DRTECH Corporation
Radiology · 133d
Cleared Mar 19, 2025
AcuPebble Ox (200)
K243092 · MNR
Acurable Limited
Anesthesiology · 170d
Cleared Mar 19, 2025
Tyber Medical Anatomical Plating System
K242486 · HRS
Tyber Medical, LLC
Orthopedic · 210d
Cleared Mar 19, 2025
Sunny
K242241 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 231d
Cleared Mar 19, 2025
Luer-Split MAJ-2092
K241842 · ODC
Olympus Medical Systems Corporation
Gastroenterology & Urology · 266d
Cleared Mar 19, 2025
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS...
K241791 · GEX
Gigaalaser Company , Ltd.
General & Plastic Surgery · 271d
Cleared Mar 18, 2025
The OsteoCentric Bone Plate and Screw System
K250494 · HRS
OsteoCentric Technologies
Orthopedic · 26d
Cleared Mar 18, 2025
Aglaia LED Beauty Device (BP-D2309)
K250413 · OHS
Shenzhen Perfect Idea Technology Limited
General & Plastic Surgery · 33d
Cleared Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · LQR
Olympus Medical Systems Corp.
Gastroenterology & Urology · 97d
Cleared Mar 18, 2025
Lux HD 35 Detector (Lux HD 35)
K243556 · MQB
Iray Imaging Technology (Haining)...
Radiology · 120d
Cleared Mar 18, 2025
QuikClot Control+ Hemostatic Device
K243553 · POD
Teleflex Medical
General & Plastic Surgery · 120d