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
1609–1632 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 04, 2021
Private Stock Labs Surgical Face Mask
K211425 · FXX
J.K. Private Stock, Inc.
General Hospital · 150d
Cleared Sep 30, 2021
SteriCap Mini Needle and Standard Needles
K212805 · FMI
Ocuject, LLC
General Hospital · 28d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609 · FPA
Baxter Healthcare Corporation
General Hospital · 294d
Cleared Sep 29, 2021
DR Safety Syringe, Sterile Hypodermic needle for Single use
K212226 · MEG
Zhuhai DR Medical Instruments Co., Ltd.
General Hospital · 75d
Cleared Sep 29, 2021
Disposable Nitrile Gloves
K211781 · LZA
Jiangsu Jinke Protective Equipment...
General Hospital · 112d
Cleared Sep 29, 2021
UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM...
K210513 · FXX
Universal Incorporation
General Hospital · 218d
Cleared Sep 28, 2021
Disposable surgical mask
K211794 · FXX
Shanghai No.9 Knitting Mill Co., Ltd.
General Hospital · 110d
Cleared Sep 28, 2021
Surgical Face Mask (Model: CM2006, CM2008, A88)
K210878 · FXX
Shenzhen Realtone Medical Appliance...
General Hospital · 188d
Cleared Sep 28, 2021
ThermArt (Model IR-EFT)
K202481 · FLL
Comper Chuangxiang (Beijing)...
General Hospital · 396d
Cleared Sep 27, 2021
Disposable Vinyl Examination Gloves
K211236 · LYZ
Tangshan Hongyun Healthcare Products...
General Hospital · 154d
Cleared Sep 27, 2021
B Dispensing Line
K203674 · LHI
Aea Srl
General Hospital · 285d
Cleared Sep 26, 2021
Surgical Mask
K210908 · FXX
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 181d
Cleared Sep 26, 2021
DT100 Digital Thermometer
K203731 · FLL
Smart Technology Co., Ltd.
General Hospital · 279d
Cleared Sep 26, 2021
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter,...
K202459 · CAH
Pharma System AB
General Hospital · 395d
Cleared Sep 26, 2021
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
K201592 · KGO
Cardinal Health200, LLC
General Hospital · 471d
Cleared Sep 24, 2021
IV Administration Sets
K202618 · FPA
B.Braun Medical, Inc.
General Hospital · 379d
Cleared Sep 23, 2021
Synthetic Vinyl Examination Gloves
K212002 · LYZ
Yunnan Huazhiyuan Medical Technology...
General Hospital · 87d
Cleared Sep 23, 2021
Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
K211827 · FXX
Zhejiang Lanhine Medical Products, Ltd.
General Hospital · 101d
Cleared Sep 23, 2021
OnGuard2 Chemfort Closed Administration (CADM)
K210707 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 197d
Cleared Sep 23, 2021
Sterile Hypodermic Needles for Single Use
K210232 · FMI
Zhejiang Kangkang Medical-Devices...
General Hospital · 238d
Cleared Sep 23, 2021
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
K203662 · FLL
Yibin Junxin Electronics Technology...
General Hospital · 282d
Cleared Sep 22, 2021
Banyan USA Surgical Mask Level 3
K211097 · FXX
Banyan USA, LLC
General Hospital · 162d
Cleared Sep 22, 2021
3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties...
K210772 · FXX
Vr Vertical, LLC Dba Xrgo
General Hospital · 191d
Cleared Sep 21, 2021
Disposable Nitrile Examination Gloves
K211073 · LZA
Foshan Kangkang Biotechnology Co., Ltd.
General Hospital · 162d