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
721–744 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 07, 2023
Celerity™ HP Chemical Indicator
K231488 · JOJ
Steris
General Hospital · 76d
Cleared Aug 07, 2023
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy...
K223713 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 238d
Cleared Aug 07, 2023
V-PRO maX 2 Low Temperature Sterilization System
K223476 · MLR
STERIS Corporation
General Hospital · 262d
Cleared Aug 04, 2023
iTEMPSHIELD
K232010 · FLL
Aion Biosystems, Inc.
General Hospital · 29d
Cleared Aug 03, 2023
Surgical Face Masks, Model: EFMDS-L50Pn BLU
K230380 · FXX
Iris USA
General Hospital · 171d
Cleared Aug 02, 2023
Chemfort® Catheter Adaptor
K231286 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Jul 28, 2023
3 Layer Surgical Mask (134252531)
K231618 · FXX
Original Mattress Factory, Inc.
General Hospital · 56d
Cleared Jul 27, 2023
Altaviz Needle Kit II
K231261 · FMI
Altaviz, LLC
General Hospital · 87d
Cleared Jul 27, 2023
Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™...
K230838 · FYA
Cardinal Health200, LLC
General Hospital · 122d
Cleared Jul 25, 2023
EZ-IO Intraosseous Vascular Access System
K231924 · FMI
Teleflex Medical
General Hospital · 25d
Cleared Jul 25, 2023
A-TAP (previously called Arthrotap)
K231900 · FMF
Elcam Medical Acal
General Hospital · 27d
Cleared Jul 24, 2023
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with...
K223752 · LZA
Central Medicare Sdn Bhd
General Hospital · 221d
Cleared Jul 21, 2023
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
K231161 · NGT
Becton, Dickinson and Company
General Hospital · 88d
Cleared Jul 21, 2023
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with...
K231021 · LZA
Kimberly Clark Corporation
General Hospital · 102d
Cleared Jul 21, 2023
enspire 300 Series Automated Endoscope Reprocessor System
K230560 · NZA
STERIS Corporation
General Hospital · 143d
Cleared Jul 21, 2023
Three Way Stop Cock
K223499 · FMG
M/S Romsons International
General Hospital · 242d
Cleared Jul 21, 2023
Infrared Thermometer, Model: IR8807
K223037 · FLL
Shen Zhen Rong Feng Technology Co., Ltd.
General Hospital · 295d
Cleared Jul 21, 2023
BD Alaris™ Pump Infusion Sets
K221327 · FPA
Care Fusion
General Hospital · 441d
Cleared Jul 21, 2023
BD Alaris™ Pump Epidural Infusion Set
K221319 · PWH
Care Fusion
General Hospital · 441d
Cleared Jul 21, 2023
BD Alaris System with Guardrails Suite MX v12.1.2
K211218 · FRN
Carefusion 303, Inc.
General Hospital · 819d
Cleared Jul 20, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with...
K230875 · LZA
Central Medicare Sdn Bhd
General Hospital · 112d
Cleared Jul 18, 2023
Hypodermic Syringes & Needle
K222925 · FMF
Lifelong Meditech Private Limited
General Hospital · 295d
Cleared Jul 18, 2023
FMT Reusable Temperature Probes
K213100 · FLL
Metko Medikal VE Ttbbi Cihazlar D1s...
General Hospital · 662d
Cleared Jul 17, 2023
Revital-Ox PAA High Level Disinfectant Chemical Indicator
K230558 · JOJ
STERIS Corporation
General Hospital · 139d