FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
11233–11256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 2022
Total Bilirubin2
K223324 · CIG
Abbott Ireland Diagnostics Division
Chemistry · 59d
Cleared Dec 29, 2022
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
K223592 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Dec 29, 2022
Reflow System Mini and ReFlow Mini Flusher
K223603 · JXG
Anuncia Medical, Inc.
Neurology · 27d
Cleared Dec 29, 2022
CLEAR+BRILLIANT TOUCH® Laser System
K223647 · GEX
Solta Medical, Inc.
General & Plastic Surgery · 23d
Cleared Dec 28, 2022
nView s1 with nav option
K221344 · OWB
Nview Medical
Radiology · 233d
Cleared Dec 28, 2022
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 203d
Cleared Dec 28, 2022
StageOne™ Select Hip Cement Spacer Molds
K222760 · MBB
Biomet, Inc.
Orthopedic · 106d
Cleared Dec 28, 2022
BD AutoShield Duo™ Pen Needle
K223286 · FMI
Becton, Dickinson and Company
General Hospital · 64d
Cleared Dec 28, 2022
Medussa-PL Cage
K223654 · MAX
Medyssey USA, Inc.
Orthopedic · 22d
Cleared Dec 27, 2022
R:GEN
K220974 · HQF
Lutronic Vision, Inc.
Ophthalmic · 267d
Cleared Dec 27, 2022
IOB Warming Blankets
K221669 · DWJ
Iob Medical, Inc.
Cardiovascular · 201d
Cleared Dec 27, 2022
Access Total ßhCG (5th IS)
K221990 · DHA
Beckman Coulter, Inc.
Chemistry · 174d
Cleared Dec 27, 2022
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
K222978 · QUW
Xiros, Ltd.
Orthopedic · 90d
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