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
11689–11712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2022
Oxygen Concentrator, Model JAY-5AW
K213210 · CAW
Longfian Scitech Co., Ltd.
Anesthesiology · 435d
Cleared Dec 08, 2022
Sleeved IC
K220667 · EZD
Hollister Incorporated
Gastroenterology & Urology · 276d
Cleared Dec 08, 2022
LED Curing Light
K220826 · EBZ
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 261d
Cleared Dec 08, 2022
Southern Transforaminal Lumbar Interbody Fusion (TLIF)
K221182 · MAX
Southern Medical (Pty) , Ltd.
Orthopedic · 227d
Cleared Dec 08, 2022
LED Eye Perfector, model: EY-36A, EY-36B
K221444 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 204d
Cleared Dec 08, 2022
YY-A02-B Overlapped Compression Therapy
K221862 · IRP
Huizhou Xinyi Technology Co., Ltd.
Physical Medicine · 164d
Cleared Dec 08, 2022
CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
K222038 · QNR
Abbott (Formerly Thoratec Corporation)
Cardiovascular · 150d
Cleared Dec 08, 2022
IRRAflow Active Fluid Exchange System (AFES)
K222471 · JXG
Irras USA
Neurology · 114d
Cleared Dec 08, 2022
Yomi Robotic System
K222750 · QRY
Neocis, Inc.
Dental · 87d
Cleared Dec 08, 2022
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...
K222837 · MCW
Spectranetics, Inc.
Cardiovascular · 79d
Cleared Dec 08, 2022
MAVERICK Mini External Fixation System
K223112 · JDW
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Dec 08, 2022
8ch Wrist Coil
K223239 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 49d
Cleared Dec 08, 2022
InkSpace Imaging Body Array
K223487 · MOS
Inkspace Imaging, Inc.
Radiology · 17d
Cleared Dec 07, 2022
PVC Hydrophilic Urethral Catheter
K212567 · EZD
Chengdu Daxan Innovative Medical...
Gastroenterology & Urology · 478d
Cleared Dec 07, 2022
Dexcom G7 Continuous Glucose Monitoring System
K213919 · QBJ
Dexcom, Inc.
Chemistry · 357d
Cleared Dec 07, 2022
HydroMID 4F Single Lumen Midline Catheter
K220772 · FOZ
Access Vascular, Inc.
General Hospital · 266d
Cleared Dec 07, 2022
OAKTREE Anterior Lumbar Plate and Screw System
K220843 · KWQ
Oak Tree Engineering, LLC
Orthopedic · 259d
Cleared Dec 07, 2022
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with...
K221626 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 184d
Cleared Dec 07, 2022
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221836 · CAH
Dr?gerwerk AG & Co KGaA
General Hospital · 167d
Cleared Dec 07, 2022
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
K221842 · QSE
Roche Diagnostics
Immunology · 166d
Cleared Dec 07, 2022
Ultrasound System 2300
K222441 · IYN
Bk Medical Aps
Radiology · 117d
Cleared Dec 07, 2022
3-Ply Disposable Medical Mask
K223045 · FXX
Wealth Lead Industrial Limited
General Hospital · 69d
Cleared Dec 07, 2022
ViewFlex Xtra ICE Catheter
K223077 · OBJ
Irvine Biomedical, A St. Jude Medical...
Cardiovascular · 68d
Cleared Dec 07, 2022
Disposable Nitrile Examination Glove
K223281 · LZA
Anhui Kindguard Medical Supplies...
General Hospital · 43d