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
13369–13392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2022
MICROLET NEXT lancing device, MICROLET Lancet
K220633 · QRL
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 91d
Cleared Jun 03, 2022
Knee 3
K220652 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Jun 03, 2022
Surgical Gown, Blue, Sterile
K220665 · FYA
Excellent Medical Technology Group...
General Hospital · 88d
Cleared Jun 03, 2022
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy...
K220672 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 88d
Cleared Jun 03, 2022
CIRCUL8 Connect DVT Prevention Device
K220761 · JOW
Ortho8, Inc.
Cardiovascular · 80d
Cleared Jun 03, 2022
21HQ613D
K221061 · PGY
Lg Electronics.Inc
Radiology · 53d
Cleared Jun 03, 2022
BriefCase
K221314 · QAS
Aidoc Medical , Ltd.
Radiology · 29d
Cleared Jun 02, 2022
Hemosure Accu-Reader A100
K200754 · OOX
W.H.P.M., Inc.
Hematology · 801d
Cleared Jun 02, 2022
Q Patch
K210758 · MWJ
Medicalgorithmics S.A.
Cardiovascular · 444d
Cleared Jun 02, 2022
Minjie Catheter System
K212288 · QJP
Kai Medtech, LLC
Neurology · 316d
Cleared Jun 02, 2022
Endoscopic Injection Needle
K213239 · FBK
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 245d
Cleared Jun 02, 2022
EpilME
K213261 · GEX
Neauvia North America
General & Plastic Surgery · 245d
Cleared Jun 02, 2022
Q2 IV Administration Sets
K213588 · FPA
Quest Medical, Inc.
General Hospital · 202d
Cleared Jun 02, 2022
Leaseir MHR Xcell
K214049 · GEX
Leaseir Technologies, Slu
General & Plastic Surgery · 157d
Cleared Jun 02, 2022
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K220008 · NCX
Zoll Circulation, Inc.
Neurology · 149d
Cleared Jun 02, 2022
Rayvolve
K220164 · QBS
Azmed Sas
Radiology · 133d
Cleared Jun 02, 2022
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile...
K220541 · LZA
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 02, 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile...
K220547 · LZA
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 02, 2022
Zavation eZspand Interbody System
K220581 · MAX
Zavation Medical Products, LLC
Orthopedic · 93d
Cleared Jun 02, 2022
Boss Crossing Support Catheter
K220632 · DQY
Marvao Medical Devices, Ltd.
Cardiovascular · 90d
Cleared Jun 02, 2022
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
K220751 · NHA
Institut Straumann AG
Dental · 79d
Cleared Jun 02, 2022
M6-C Artificial Cervical Disc Instruments AS
K220861 · QLQ
Spinal Kinetics, LLC
Orthopedic · 70d
Cleared Jun 02, 2022
IPL Hair Removal
K220927 · OHT
Shenzhen Qiaochengli Technology Co.,...
General & Plastic Surgery · 63d
Cleared Jun 02, 2022
Restoris Multi-Compartmental Knee System
K220930 · HSX
Mako Surgical Corp.
Orthopedic · 63d