Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
817–840 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 28, 2023
Kurin Blood Culture Collection Set with Kurin Lock Technology
K220677 · JKA
Kurin, Inc.
General Hospital · 416d
Cleared Apr 27, 2023
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke...
K230547 · GEI
Conmed Corporation
General Hospital · 58d
Cleared Apr 27, 2023
Biodegradable Powder Free Nitrile Examination Glove, Blue Color,...
K221983 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 295d
Cleared Apr 26, 2023
SafeAir combi (SFR-combi-US)
K223932 · GEI
Lina Medical Aps
General Hospital · 117d
Cleared Apr 20, 2023
Neodent Implant System - Helix Short Surgical Kit Cases
K223662 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 135d
Cleared Apr 19, 2023
NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse...
K220288 · FPA
Np Medical, Inc.
General Hospital · 442d
Cleared Apr 14, 2023
OSPREY PERIPHERAL IV Catheter System
K223018 · FOZ
Skydance Vascular, Inc.
General Hospital · 197d
Cleared Apr 14, 2023
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for...
K220345 · MLR
Plasmapp Co,., Ltd.
General Hospital · 431d
Cleared Apr 13, 2023
Sterile Nitrile Surgical Gloves Powder Free
K222350 · KGO
Jr Engineering & Medical Technologies...
General Hospital · 253d
Cleared Apr 12, 2023
Polyfusion IV Administration Sets
K220312 · FPA
Poly Medicure Limited
General Hospital · 434d
Cleared Apr 07, 2023
BD SmartSite™ Needle-Free Connector
K223088 · FPA
Care Fusion
General Hospital · 189d
Cleared Apr 06, 2023
Disposable Insulin Pen Needle
K222739 · FMI
Hantech Medical Device Co., Ltd.
General Hospital · 209d
Cleared Mar 31, 2023
Spectrum IQ Infusion System with Dose IQ Safety Software
K230041 · FRN
Baxter Healthcare Corporation
General Hospital · 84d
Cleared Mar 31, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN
Baxter Healthcare Corporation
General Hospital · 86d
Cleared Mar 30, 2023
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with...
K220088 · LZA
Professional Latex Sdn Bhd
General Hospital · 443d
Not Cleared Mar 30, 2023
SNOO Smart Sleeper
DEN210039 · QTG
Happiest Baby, Inc.
General Hospital · 556d
Cleared Mar 28, 2023
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
K230582 · MED
STERIS Corporation
General Hospital · 26d
Cleared Mar 27, 2023
Disposable Surgical Face Mask
K223823 · FXX
Efofex, Inc.
General Hospital · 96d
Cleared Mar 25, 2023
Vinyl examination gloves
K230046 · LYZ
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 78d
Cleared Mar 25, 2023
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use,...
K220644 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 386d
Cleared Mar 24, 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for...
K230002 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 80d
Cleared Mar 24, 2023
Blood Collection Needle (with/without Needle Holder)
K223323 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 144d
Cleared Mar 24, 2023
Medline Surgical Face Mask and Medline Procedural Face Mask
K223236 · FXX
Medline Industries, LP
General Hospital · 156d
Cleared Mar 24, 2023
BD Texium™ Closed Male Luer
K223076 · ONB
Care Fusion
General Hospital · 175d