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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
433–456 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 25, 2024
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001,...
K240824 · LZA
Ningxia Qiaoen Medical Technology...
General Hospital · 91d
Cleared Jun 21, 2024
ToxiSeal™ Vial Adaptor with External Flip Balloon
K241476 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 28d
Cleared Jun 21, 2024
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
K241442 · KPE
Epic Medical Pte. , Ltd.
General Hospital · 30d
Cleared Jun 21, 2024
Medicom Sterilization Wrap
K240862 · FRG
Medicom Group, Inc.
General Hospital · 85d
Cleared Jun 21, 2024
SteadyTemp
K233280 · FLL
Steadysense GmbH
General Hospital · 266d
Cleared Jun 21, 2024
PRESSUREALERT® Pressure Monitoring System
K233096 · SBO
Position Health, LLC
General Hospital · 269d
Cleared Jun 21, 2024
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)
K232807 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 283d
Cleared Jun 18, 2024
Pen Injector
K240774 · FMF
Wuxi Nest Biotechnology Co., Ltd.
General Hospital · 89d
Cleared Jun 14, 2024
Airdog X8 Air Purifier (KJ800F-X8)
K240696 · FRF
Suzhou Beiang Smart Technology Co., Ltd.
General Hospital · 92d
Cleared Jun 14, 2024
Fluidshield* 2 Fog-Free Surgical Mask (62113)
K232812 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 276d
Cleared Jun 14, 2024
Disposable High-pressure Extension Lines
K230668 · DXT
Precision Medical Plastics , Ltd.
General Hospital · 462d
Cleared Jun 12, 2024
EO Chex Indicator Tape
K240910 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 71d
Cleared Jun 12, 2024
Remunity System
K240256 · QJY
Deka Research and Development
General Hospital · 133d
Cleared Jun 12, 2024
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile...
K232950 · FMF
Perfect Medical Industry (Vn) Co., Ltd.
General Hospital · 266d
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