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
361–384 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 15, 2024
Getinge Assured MI Steam Migrating Integrator
K242795 · JOJ
Steritec Products Mfg. (A Getinge...
General Hospital · 29d
Cleared Oct 12, 2024
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
K242812 · LZA
Nb Medical Company Limited
General Hospital · 24d
Cleared Oct 10, 2024
ProSeal™ In Line Pump Set (423850)
K241735 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 115d
Cleared Oct 07, 2024
DEKA Infusion System, DEKA Administration Set
K242693 · LDR
Deka Research and Development...
General Hospital · 28d
Cleared Oct 07, 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K242208 · FRG
Primed Medical Products, Inc.
General Hospital · 70d
Cleared Oct 07, 2024
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152 · MEB
Epic Medical Pte. , Ltd.
General Hospital · 76d
Cleared Oct 03, 2024
Curlin 8000 Ambulatory Infusion System
K242660 · FRN
Zevex, Inc.
General Hospital · 29d
Cleared Sep 30, 2024
Kem Medical Lead-free Chemical Indicators for Steam Sterilization
K241836 · JOJ
Kem Medical Products Corporation
General Hospital · 97d
Cleared Sep 27, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,...
K241909 · LZA
O&M Halyard, Inc.
General Hospital · 88d
Cleared Sep 27, 2024
trophon Wireless Ultrasound Probe Holder
K241536 · OUJ
Nanosonics Limited
General Hospital · 120d
Cleared Sep 27, 2024
Aulisa Temperature Module (TM0002)
K240220 · FLL
Taiwan Aulisa Medical Devices...
General Hospital · 245d
Cleared Sep 26, 2024
Verifine® Pen Needles
K242632 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 23d
Cleared Sep 20, 2024
Luer Lock Syringe with Safety Needle
K241821 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 88d
Cleared Sep 20, 2024
Ecomed Disposable Administration Sets
K234129 · FPA
Ecomed Solutions, LLC
General Hospital · 267d
Cleared Sep 18, 2024
Perpak™ Sterilization Tyvek Pouch
K241123 · FRG
Km Corp.
General Hospital · 148d
Cleared Sep 18, 2024
LOWTEM Crystal 120
K231893 · MLR
Lowtem Co., Ltd.
General Hospital · 448d
Cleared Sep 18, 2024
Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene®...
K231383 · FRC
Terragene S.A.
General Hospital · 495d
Cleared Sep 17, 2024
Medline Reusable Sterilization Wrappers
K234132 · FRG
Medline Industries, LP
General Hospital · 264d
Cleared Sep 16, 2024
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization...
K234050 · FRG
O&M Halyard, Inc.
General Hospital · 270d
Cleared Sep 12, 2024
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V
K241710 · FRC
3M Company
General Hospital · 90d
Cleared Sep 11, 2024
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46...
K241745 · LZA
Ksg Medicare Sdn. Bhd.
General Hospital · 85d
Cleared Sep 10, 2024
ProPel SG3™ Surgical Gown
K241214 · FYA
Standard Textile Co., Inc.
General Hospital · 133d
Cleared Sep 09, 2024
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K240266 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 222d
Cleared Sep 06, 2024
nextaro® va, 15mm, 5µm
K241976 · LHI
Sfm Medical Devices GmbH
General Hospital · 63d