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
457–480 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 28, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs...
K240629 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 83d
Cleared May 24, 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K233777 · FRG
Primed Medical Products, Inc.
General Hospital · 182d
Cleared May 23, 2024
AirKEE T900
K232642 · FRA
Healkee Medical Pte, Ltd.
General Hospital · 267d
Cleared May 21, 2024
ProSeal™ Injection Site Extended Male Luer Lock (422140)
K240433 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 97d
Not Cleared May 21, 2024
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder...
DEN230068 · JOJ
3M Company
General Hospital · 235d
Cleared May 20, 2024
Disposable Vinyl Examination Gloves
K241252 · LYZ
Anqing Pukang Medical Technology Co.,...
General Hospital · 17d
Cleared May 17, 2024
Curlin 8000 Ambulatory Infusion System
K232793 · FRN
Zevex, Inc.
General Hospital · 249d
Cleared May 16, 2024
AirKEE P900
K232933 · FRA
Healkee Medical Pte, Ltd.
General Hospital · 239d
Cleared May 16, 2024
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer...
K232849 · FYC
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 245d
Cleared May 13, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with...
K232614 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 259d
Cleared May 10, 2024
Filter Needle for Single Use
K233277 · FPB
Hangzhou Qiantang Longyue...
General Hospital · 224d
Cleared May 10, 2024
Disposable infusion set with needle
K232475 · FPA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 268d
Cleared May 03, 2024
Vial2Bag Advanced® 20mm Admixture Device
K240940 · LHI
West Pharmaceutical Services, Inc.
General Hospital · 28d
Cleared May 01, 2024
Vial Adapter with Filter
K233284 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 215d
Cleared Apr 22, 2024
Black Pearl Nitrile Examination Glove
K232319 · LZA
Ug Global Resources Sdn. Bhd.
General Hospital · 263d
Cleared Apr 19, 2024
ulricheasyINJECT Max 2M (XD 10140)
K233737 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 149d
Cleared Apr 19, 2024
AccuCath Ace™ Intravascular Catheter
K233106 · FOZ
Bard Access Systems, Inc. (C.R. Bard,...
General Hospital · 205d
Cleared Apr 18, 2024
Disposable Medical Face Mask (M643BE)
K240258 · FXX
Makrite Industries, Inc.
General Hospital · 78d
Cleared Apr 17, 2024
Celerity Chemical Indicator for enspire 3000 CLCSPS
K240032 · JOJ
STERIS Corporation
General Hospital · 104d
Cleared Apr 16, 2024
nextaro® v, 20/20
K240748 · LHI
Sfm Medical Devices GmbH
General Hospital · 28d
Cleared Apr 12, 2024
Medical electronic thermometer (FC01, FC02)
K240109 · FLL
Zhuzhou Goldenhot Medical Technology...
General Hospital · 87d
Cleared Apr 12, 2024
Disposable Extension Set
K222766 · FPA
Shandong Ande Healthcare Apparatus...
General Hospital · 577d
Cleared Apr 10, 2024
CELERITY HP Indicator Tape
K240760 · JOJ
Steris
General Hospital · 21d
Cleared Apr 10, 2024
8Q10 Surclear Smoke Plume Evacuation System
K233789 · FYD
Surnic Corporation
General Hospital · 134d