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
73–96 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 05, 2026
Temperature probes (T2252-PG)
K253162 · FLL
Unimed Medical Supplies, Inc.
General Hospital · 252d
Cleared Jun 04, 2026
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
K252575 · FYA
New York Embroidery Studio (NYES)
General Hospital · 294d
Cleared Jun 03, 2026
Nitrile Disposable Examination Gloves
K260806 · LZA
Vista Industries,, LLC
General Hospital · 83d
Cleared Jun 03, 2026
Straumann® ProClean™ Cassette (041.800
K260726 · KCT
Institut Straumann AG
General Hospital · 90d
Cleared Jun 03, 2026
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy...
K260703 · LZA
S&S Glove Corporation
General Hospital · 91d
Cleared Jun 03, 2026
SteriTite Container System with MediTray Products
K252854 · KCT
Case Medical, Inc.
General Hospital · 268d
Cleared Jun 02, 2026
Female Culture Device
K252899 · JKA
Zhejiang Kindly Medical Device Co., Ltd.
General Hospital · 264d
Cleared May 28, 2026
Dukal Crepe Paper Sterilization Wrap
K252823 · FRG
Dukal, LLC
General Hospital · 266d
Cleared May 22, 2026
Guanhong Sharps Container (GHW-1F1)
K253773 · MMK
Taizhou Huangyan Guanhong Plastic...
General Hospital · 177d
Cleared May 22, 2026
Sterile Latex Powder Free Surgical Gloves
K253060 · KGO
Protect Gloves Company Limited
General Hospital · 242d
Cleared May 21, 2026
Sofjec (Single use Needle)
K253112 · FMF
Hlb Lifescience Co., Ltd.
General Hospital · 239d
Cleared May 18, 2026
HALYARD* ONE-STEP* Sterilization Wrap
K253454 · FRG
O&M Halyard, Inc.
General Hospital · 227d
Cleared May 15, 2026
Introcan Safety® Deep Access XL IV Catheter
K253235 · FOZ
B.Braun Medical, Inc.
General Hospital · 228d
Cleared May 15, 2026
Iso-Gard Filter Straight
K252643 · CAH
Teleflex Medical Sdn. Bhd.
General Hospital · 267d
Cleared May 14, 2026
Disposable Syringes with Accessories for Power Injectors (900103T)
K252652 · DXT
Fortis Biosolutions Company Limited
General Hospital · 265d
Cleared May 13, 2026
ACIST Pro Diagnostic System (019304)
K252653 · DXT
Acist Medical Systems, Inc.
General Hospital · 264d
Cleared May 13, 2026
VeraPro S100 Multi-Use Syringe (018808)
K252638 · DXT
Acist Medical Systems, Inc.
General Hospital · 266d
Cleared May 12, 2026
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
K260725 · FYA
Hindernis DE Mexico, S.A.P.I. DE C.V.
General Hospital · 68d
Cleared May 04, 2026
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P,...
K252543 · FPA
Amsino International, Inc.
General Hospital · 265d
Not Cleared May 01, 2026
Prolystica Pass Thru Disinfectant Wipes
DEN240075 · SHM
Steris
General Hospital · 505d
Cleared Apr 30, 2026
Ambu® Virobac II® Exhalation Filter
K251583 · CAH
Ambu A/S
General Hospital · 342d
Cleared Apr 29, 2026
Paptizer 360
K252471 · QXQ
LiViliti Health Products Corporation
General Hospital · 266d
Cleared Apr 28, 2026
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · FYA
Cardinal Health 200, LLC
General Hospital · 211d
Cleared Apr 24, 2026
°M Warmer System with °M Station
K260988 · LGZ
Mequ A/S
General Hospital · 30d