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
169–192 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 03, 2025
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 280d
Cleared Dec 02, 2025
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
K250884 · NGT
Becton, Dickinson and Company
General Hospital · 253d
Cleared Nov 26, 2025
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
K252355 · PTI
Sb-Kawasumi Laboratories, Inc.
General Hospital · 120d
Cleared Nov 21, 2025
StaClear Syringe (SC250AN)
K251849 · QLY
Staclear, Inc.
General Hospital · 158d
Cleared Nov 21, 2025
Pen Injector Needle 32.5
K250700 · FMI
Terumo Corporation
General Hospital · 259d
Cleared Nov 18, 2025
Fluido Compact System
K252636 · LGZ
The Surgical Company International B.V.
General Hospital · 90d
Cleared Nov 18, 2025
ulricheasyINJECT Max 2M (XD 10140)
K252281 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 119d
Cleared Nov 17, 2025
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile...
K251141 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 217d
Cleared Nov 14, 2025
Biomoneta Avata Rx
K251872 · FRF
Biomoneta Research Private Limited
General Hospital · 149d
Cleared Nov 14, 2025
Sterilization Trays
K251756 · KCT
Paragon Implant Mfg., LLC
General Hospital · 158d
Cleared Nov 07, 2025
ulrichINJECT CT Motion (XD 8000)
K251295 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 196d
Cleared Nov 05, 2025
Polyshield Safety IV Catheters
K252677 · FOZ
Poly Medicure Limited
General Hospital · 72d
Cleared Nov 04, 2025
PRIMED Surgical and Procedure Masks
K252964 · FXX
Primed Medical Products, Inc.
General Hospital · 48d
Cleared Nov 04, 2025
Merit Syringe
K250853 · FMF
Merit Medical Systems, Inc.
General Hospital · 228d
Cleared Oct 31, 2025
Chex-All Sterilization Pouches and Tubes
K250306 · FRG
Propper Manufacturing Co., Inc.
General Hospital · 270d
Cleared Oct 30, 2025
BD Alaris Pump Infusion Set
K250325 · FPA
Carefusion (Bd)
General Hospital · 267d
Cleared Oct 27, 2025
Disposable Vinyl Examination Gloves
K252467 · LYZ
Viet Phu Trade and Import Export Co.,...
General Hospital · 82d
Cleared Oct 24, 2025
Medline Bag Decanter
K250345 · LHI
Medline Industries, LP
General Hospital · 260d
Cleared Oct 23, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs,...
K250861 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 216d
Cleared Oct 22, 2025
Giraffe OmniBed Carestation (CS1)
K251663 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 145d
Cleared Oct 21, 2025
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
K253033 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 29d
Cleared Oct 17, 2025
Program insite® Powder-Free, Disposable Nitrile Exam Gloves
K252075 · LZA
Program Insite, LLC
General Hospital · 107d
Cleared Oct 16, 2025
Profoject™ Disposable Needle
K252631 · FMI
CMT Health PTE., Ltd.
General Hospital · 57d
Cleared Oct 15, 2025
Sure-Fine Insulin Syringes
K250510 · FMF
Shina Med Corporation
General Hospital · 236d