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
529–552 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 01, 2024
Surgical Gown (40083)
K233183 · FYA
Ammex-Weida (Hubei) Health and Safety...
General Hospital · 126d
Cleared Feb 01, 2024
Sterile Safety Hypodermic Needles for Single Use
K232165 · FMI
Berpu Medical Technology Co., Ltd.
General Hospital · 195d
Cleared Jan 31, 2024
Digital Thermometer, Model T28, T28L
K232678 · FLL
Guangdong Genial Technology Co., Ltd.
General Hospital · 152d
Cleared Jan 26, 2024
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested...
K233598 · LZA
Anhui Intco Medical Products Co., Ltd.
General Hospital · 78d
Cleared Jan 26, 2024
LifeOutcomes C-Quest™ Blood Culture Sampling Device
K231282 · JKA
Lifeoutcomes, LLC
General Hospital · 268d
Cleared Jan 19, 2024
Mix2Vial® Transfer Device
K231071 · LHI
West Pharma Services Il, Ltd.
General Hospital · 280d
Cleared Jan 16, 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use...
K233970 · LZA
Nephron Nitrile, LLC
General Hospital · 32d
Cleared Jan 16, 2024
Washtrays
K231144 · KCT
Dentsply Sirona
General Hospital · 270d
Cleared Jan 12, 2024
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use...
K233520 · LZA
Anhui Powerguard Technology Co., Ltd.
General Hospital · 72d
Cleared Jan 12, 2024
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask...
K233022 · MSH
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d
Cleared Jan 12, 2024
SoloSmart Injection Pen Adapter (SoloSmart®)
K231820 · QOG
Biocorp Production
General Hospital · 205d
Cleared Jan 12, 2024
SMB Luer lock disposable syringe
K231558 · FMF
Smb Corporation of India
General Hospital · 227d
Cleared Jan 11, 2024
ToxiSeal Vial Adapter with External Balloon
K222929 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 472d
Cleared Jan 08, 2024
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT*...
K232894 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d
Cleared Jan 03, 2024
ResQ Administration Set
K231707 · FPA
Q For Plastic Industries
General Hospital · 205d
Cleared Jan 03, 2024
Carecube Negative Pressure Isolation Chamber
K231256 · LGM
Carecubes, Inc.
General Hospital · 247d
Cleared Dec 28, 2023
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and...
K233405 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 84d
Cleared Dec 22, 2023
Anthogyr INTEGRAL Guided Surgery Cassettes
K233264 · KCT
Anthogyr
General Hospital · 84d
Cleared Dec 22, 2023
Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood...
K232881 · JKA
Jiangsu Kangbao Medical Equipment...
General Hospital · 95d
Cleared Dec 22, 2023
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344,...
K232338 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 140d
Cleared Dec 21, 2023
Kangbeier Child Surgical Mask
K221753 · OXZ
Xinxiang Kangbeier Medical Technology...
General Hospital · 553d
Cleared Dec 20, 2023
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy...
K232444 · KGO
Grand Work Plastic Products Co., Ltd.
General Hospital · 128d
Cleared Dec 19, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
K233132 · FLE
Primus Sterilizer Company, LLC
General Hospital · 83d
Cleared Dec 15, 2023
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
K233682 · OVY
STERIS Corporation
General Hospital · 29d