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
11521–11544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2022
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software...
K223094 · DQK
Abbott Medical
Cardiovascular · 88d
Cleared Dec 23, 2022
ACTOnco, ACTOnco IVD
K210017 · PZM
Act Genomics
Pathology · 718d
Cleared Dec 23, 2022
STA- NeoPTimal
K211485 · GJS
Diagnostica Stago S.A.S
Hematology · 589d
Cleared Dec 23, 2022
XENOVIEW 3.0T Chest Coil
K212239 · MOS
Polarean, Inc.
Radiology · 522d
Cleared Dec 23, 2022
CRYOcheck Chromogenic Factor IX
K214002 · GGP
Precision Biologic, Inc.
Hematology · 367d
Cleared Dec 23, 2022
AVIEW
K214036 · QIH
Coreline Soft Co., Ltd.
Radiology · 365d
Cleared Dec 23, 2022
Episealer Patellofemoral System
K221048 · KRR
Episurf Medical, Inc.
Orthopedic · 259d
Cleared Dec 23, 2022
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
K221193 · HWC
OSSIO , Ltd.
Orthopedic · 242d
Cleared Dec 23, 2022
CIMILRE Free-T2 Plus
K221708 · HGX
Cimilre Co., Ltd.
Obstetrics & Gynecology · 193d
Cleared Dec 23, 2022
ONLINE DAT Benzodiazepines II
K221765 · JXM
Roche Diagnostics
Toxicology · 189d
Cleared Dec 23, 2022
Visant Medical Canalicular Plug
K222164 · LZU
Visant Medical, Inc.
Ophthalmic · 155d
Cleared Dec 23, 2022
Smartpump 3.0 Double Electric Breast Pump
K222726 · HGX
Lansinoh Laboratories
Obstetrics & Gynecology · 106d
Cleared Dec 23, 2022
ShiNeo Silicone Implant
K222748 · MIB
Shineo Technology Co., Ltd.
General & Plastic Surgery · 102d
Cleared Dec 23, 2022
Leg Massager RF-ALM070
K222924 · IRP
Shenzhen Ruiyi Business Technology...
Physical Medicine · 88d
Cleared Dec 23, 2022
Xenoview VDP
K223071 · LLZ
Polarean, Inc.
Radiology · 84d
Cleared Dec 23, 2022
Access Vitamin B12
K223289 · CDD
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Dec 23, 2022
MR 5300 and MR 7700 R11 MR Systems
K223442 · LNH
Philips Medical Systems Nederlands B.V.
Radiology · 39d
Cleared Dec 23, 2022
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K223565 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Dec 22, 2022
Lp(a) Ultra
K211058 · DFC
SENTINEL CH. SpA
Chemistry · 622d
Cleared Dec 22, 2022
SteriKing LT-Blueline Pouches with Tyvek
K221377 · FRG
Wipak OY
General Hospital · 224d
Cleared Dec 22, 2022
Arthrex FiberTak Suture Anchor
K221396 · MBI
Arthrex, Inc.
Orthopedic · 223d
Cleared Dec 22, 2022
PerioStom Dental Dressing
K221428 · OLR
Forward Science, LLC
General & Plastic Surgery · 220d
Cleared Dec 22, 2022
TruWave Disposable Pressure Transducer
K222216 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Dec 22, 2022
Sunrise
K222262 · QRS
Sunrise SA
Anesthesiology · 147d