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
49–72 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Apr 24, 2026
SMARTeZ™ Elastomeric Infusion Pump (RS series)
K250234 · MEB
Epic Medical Pte. , Ltd.
General Hospital · 452d
Cleared Apr 22, 2026
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM...
K252306 · QVB
Steritec Products
General Hospital · 272d
Cleared Apr 20, 2026
Luminoah FLOW™ Enteral Nutrition System
K253558 · LZH
Luminoah
General Hospital · 154d
Cleared Apr 20, 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · FYA
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 213d
Cleared Apr 17, 2026
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
K252279 · FMF
Chirana T.Injecta,A.S.
General Hospital · 269d
Cleared Apr 16, 2026
Verisafe Safety Sterile Needles (SSN)
K254273 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 107d
Cleared Apr 16, 2026
High Pressure Syringe
K253048 · DXT
Shenzhen Maiwei Biotech Co., Ltd.
General Hospital · 206d
Cleared Apr 15, 2026
STERRAD 100NX Sterilization System with ALLClear Technology (10104)
K252843 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 219d
Cleared Apr 10, 2026
BD Vacutainer® Safety-Lok™ Blood Collection Set
K252506 · JKA
Becton, Dickinson and Company
General Hospital · 245d
Cleared Apr 08, 2026
Celerity 5 HP Biological Indicator (LCB052)
K260766 · FRC
STERIS Corporation
General Hospital · 30d