FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
14377–14400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 2022
Venus Bulk Flow ONE
K220605 · EBF
Kulzer, LLC
Dental · 50d
Cleared Apr 20, 2022
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K212022 · QKM
3M Company
General Hospital · 295d
Cleared Apr 20, 2022
SmoothCool HR System
K213484 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 173d
Cleared Apr 20, 2022
GEM FLOW COUPLER Monitor (GEM1020M-2)
K213974 · DPW
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 121d
Cleared Apr 20, 2022
Auxo A300, A150 and APod
K220543 · OAP
Auxo Hair, LLC
General & Plastic Surgery · 54d
Cleared Apr 20, 2022
EKOS+ Endovascular Device
K220866 · QEY
Boston Scientific
Cardiovascular · 26d
Cleared Apr 20, 2022
Saberscope5 Laparoscope
K220872 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 26d
Cleared Apr 19, 2022
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
K192931 · GKA
Helena Laboratories, Corp.
Hematology · 915d
Cleared Apr 19, 2022
Altus Spine Interbody Standalone Fusion System
K211837 · OVD
Altus Partners, LLC
Orthopedic · 309d
Cleared Apr 19, 2022
QUATERA 700
K212241 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 274d
Cleared Apr 19, 2022
Brainlab Elements Guide XT, Guide 3.0
K213930 · QQC
Brainlab AG
Neurology · 124d
Cleared Apr 19, 2022
Spartan Center Wire
K220075 · DQX
Spartan Micro, Inc.
Cardiovascular · 99d
Cleared Apr 19, 2022
General Radiography X-ray System (Model: GR10X 40K), General Radiography...
K220149 · KPR
Xera Medical Systems & Technology , Ltd.
Radiology · 90d
Cleared Apr 19, 2022
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
K220152 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 90d
Cleared Apr 19, 2022
Infinity™ OCT System and PASS OCT Spinal System
K220810 · NKG
Medicrea International
Orthopedic · 29d
Cleared Apr 18, 2022
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
K212952 · LCM
Psychemedics Corporation
Toxicology · 214d
Cleared Apr 18, 2022
KYPHON VuE Bone Cement
K220131 · NDN
Tecres S.P.A.
Orthopedic · 90d
Cleared Apr 18, 2022
Nautilus
K220871 · JAA
Dornier Medtech America, Inc.
Radiology · 24d
Cleared Apr 17, 2022
BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
K213408 · LZA
Meditech Gloves Sdn Bhd
General Hospital · 180d
Cleared Apr 15, 2022
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K212377 · NUH
Ningbo Medkinetic Medical Device Co.,...
Neurology · 256d
Cleared Apr 15, 2022
Lilliput APD System
K212522 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 247d
Cleared Apr 15, 2022
aboNT SYRINGE
K212677 · FMF
Nipro Medical Corporation
General Hospital · 234d
Cleared Apr 15, 2022
ARDO Alyssa
K212773 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 227d
Cleared Apr 15, 2022
mJOULE System and Accessories
K213350 · GEX
Sciton, Inc
General & Plastic Surgery · 189d