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
217–240 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 18, 2025
Procedure mask/Surgical mask/Face mask
K250082 · FXX
Winner Medical Co., Ltd.
General Hospital · 156d
Cleared Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
K243172 · LZA
O&M Halyard, Inc.
General Hospital · 261d
Cleared Jun 17, 2025
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested...
K243133 · LZA
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 260d
Cleared Jun 09, 2025
MallyaG Injection Pen Adapter (MallyaG)
K251500 · QOG
Biocorp Production
General Hospital · 25d
Cleared Jun 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
K251452 · FRC
Steris
General Hospital · 28d
Cleared Jun 06, 2025
GCI Sterilization Wrappers
K250321 · FRG
George Courey, Inc.
General Hospital · 122d
Cleared Jun 06, 2025
Steam Sterilizer (2545D)
K243994 · FLE
Ningbo Ican Machines Co., Ltd.
General Hospital · 162d
Cleared Jun 06, 2025
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract,...
K243694 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 189d
Cleared Jun 05, 2025
Clave™ Neutral-Displacement Needlefree Connectors
K250616 · FPA
Icu Medical, Inc.
General Hospital · 97d
Cleared Jun 04, 2025
Blood collection tube holders
K250961 · JKA
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 65d
Cleared Jun 03, 2025
DISINTEK™ PA Test Strips
K251035 · JOJ
Serim Research
General Hospital · 61d
Cleared Jun 03, 2025
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™...
K250682 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 89d
Cleared Jun 03, 2025
GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for...
K243796 · LZA
Glove One, LLC
General Hospital · 175d
Cleared May 30, 2025
ViVi® Toga Premium
K243522 · FYA
Thi Total Healthcare Innovation GmbH
General Hospital · 197d
Cleared May 30, 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 246d
Cleared May 29, 2025
ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
K251340 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 29d
Cleared May 29, 2025
BiliWrap
K243372 · LBI
Gerium Medical, Ltd.
General Hospital · 211d
Cleared May 29, 2025
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
K243309 · FMI
Terumo Europe N.V.
General Hospital · 220d
Cleared May 28, 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · FRN
Iradimed Corporation
General Hospital · 258d
Cleared May 27, 2025
Helios+ UV-C System
K242604 · QXJ
Preventamed Technologies, Inc. Dba...
General Hospital · 270d
Cleared May 23, 2025
Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
K244047 · JKA
Venocare, Inc.
General Hospital · 143d
Cleared May 22, 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 59d
Cleared May 22, 2025
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with...
K250630 · LZA
Basic Medical Technology, Inc.
General Hospital · 80d
Cleared May 16, 2025
Ruby Intravascular Catheter
K243105 · FOZ
Venocare, Inc.
General Hospital · 228d