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
9289–9312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2023
Sterile Auto-Disable Syringes with/without Needle for Single Use
K231727 · FMF
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Safety Hypodermic Needles for Single Use
K231723 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Hypodermic Needles for Single Use
K231720 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K231643 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 95d
Cleared Sep 08, 2023
Air/Water Bottle Tubing, CO2 Source Tubing
K231471 · OCX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 109d
Cleared Sep 08, 2023
Cleerly ISCHEMIA
K231335 · QXZ
Cleerly, Inc.
Cardiovascular · 123d
Cleared Sep 08, 2023
OnPoint Augmented Reality Spine System
K231284 · SBF
Onpoint Surgical, Inc.
Orthopedic · 128d
Cleared Sep 08, 2023
MaxTack™ Motorized Fixation Device
K231240 · OCW
Covidien
General & Plastic Surgery · 133d
Cleared Sep 08, 2023
AliTight
K231146 · GEI
Alic Iotech, LLC
General & Plastic Surgery · 140d
Cleared Sep 08, 2023
STarFix Designer Software C0265
K231141 · QRI
FHC, Inc.
Neurology · 140d
Cleared Sep 08, 2023
ISE Electrodes
K230890 · CEM
Randox Laboratories, Ltd.
Chemistry · 161d
Cleared Sep 08, 2023
Zeta Cranial Navigation System
K230661 · HAW
Zeta Surgical
Neurology · 182d
Cleared Sep 08, 2023
KARL STORZ Urological Laser Accessories
K230535 · GEX
Karl Storz SE & CO. KG
Gastroenterology & Urology · 193d
Cleared Sep 08, 2023
VitreJect Syringe
K230372 · QLY
Ocuject, LLC
General Hospital · 207d
Cleared Sep 08, 2023
STAT Medical Device Lancing System
K230310 · QRK
Stat Medical Devices
General & Plastic Surgery · 217d
Cleared Sep 08, 2023
Intrisound™ Tuned Lumen® 155 Hearing Aids
K223848 · QUH
Tuned , Ltd.
Ear, Nose, Throat · 260d
Cleared Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 261d
Cleared Sep 08, 2023
DeepXray
K223621 · QIH
Alpha Intelligence Manifolds, Inc.
Radiology · 277d
Cleared Sep 08, 2023
Minuteful-kidney test
K222921 · JIR
Healthy.Io, Ltd.
Chemistry · 347d
Cleared Sep 08, 2023
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
K213510 · LTK
Siemens Healthcare Diagnostics...
Immunology · 675d
Cleared Sep 07, 2023
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K232443 · MMX
Argon Medical Devices, Inc.
Cardiovascular · 24d
Cleared Sep 07, 2023
Carescape SpO2 - Masimo
K232389 · DQA
Masimo Corporation
Anesthesiology · 29d
Cleared Sep 07, 2023
Steriking® LT-Blueline Pouches with Tyvek®
K231999 · FRG
Wipak OY
General Hospital · 64d
Cleared Sep 07, 2023
Steriking® LT-Blueline Pouches with Tyvek®
K231996 · FRG
Wipak OY
General Hospital · 64d