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
481–504 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 11, 2024
MetriCide™ OPA Plus Solution Test Strip
K241344 · JOJ
Steris
General Hospital · 29d
Cleared Jun 07, 2024
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft...
K232806 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 269d
Cleared Jun 07, 2024
Steriking® Pouch for Robotic Instruments
K232625 · FRG
Wipak OY
General Hospital · 283d
Cleared Jun 06, 2024
Grande Medical Masks, Model SF-600
K232968 · FXX
Golden Grande Corp.
General Hospital · 259d
Cleared Jun 05, 2024
Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
K240648 · FLL
Radiant Innovation, Inc.
General Hospital · 90d
Cleared Jun 04, 2024
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
K232820 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 265d
Cleared Jun 03, 2024
Perforated Baskets
K231291 · KCT
Richard Wolf Medical Instruments...
General Hospital · 396d
Cleared May 31, 2024
Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
K232943 · QNQ
Smiths Medical Asd, Inc.
General Hospital · 254d
Cleared May 31, 2024
°M Warmer System
K232107 · LGZ
Mequ A/S
General Hospital · 322d
Cleared May 29, 2024
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe
K241190 · QNQ
Poonglim Pharmatech, Inc.
General Hospital · 30d
Cleared May 28, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs...
K240629 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 83d
Cleared May 24, 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K233777 · FRG
Primed Medical Products, Inc.
General Hospital · 182d
Cleared May 23, 2024
AirKEE T900
K232642 · FRA
Healkee Medical Pte, Ltd.
General Hospital · 267d
Cleared May 21, 2024
ProSeal™ Injection Site Extended Male Luer Lock (422140)
K240433 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 97d
Not Cleared May 21, 2024
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder...
DEN230068 · JOJ
3M Company
General Hospital · 235d
Cleared May 20, 2024
Disposable Vinyl Examination Gloves
K241252 · LYZ
Anqing Pukang Medical Technology Co.,...
General Hospital · 17d
Cleared May 17, 2024
Curlin 8000 Ambulatory Infusion System
K232793 · FRN
Zevex, Inc.
General Hospital · 249d
Cleared May 16, 2024
AirKEE P900
K232933 · FRA
Healkee Medical Pte, Ltd.
General Hospital · 239d
Cleared May 16, 2024
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer...
K232849 · FYC
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 245d
Cleared May 13, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with...
K232614 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 259d
Cleared May 10, 2024
Filter Needle for Single Use
K233277 · FPB
Hangzhou Qiantang Longyue...
General Hospital · 224d
Cleared May 10, 2024
Disposable infusion set with needle
K232475 · FPA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 268d
Cleared May 03, 2024
Vial2Bag Advanced® 20mm Admixture Device
K240940 · LHI
West Pharmaceutical Services, Inc.
General Hospital · 28d
Cleared May 01, 2024
Vial Adapter with Filter
K233284 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 215d