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
1153–1176 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 05, 2022
Q2 Blood Administration Sets
K213846 · FPA
Quest Medical, Inc.
General Hospital · 177d
Cleared Jun 03, 2022
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy...
K220672 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 88d
Cleared Jun 03, 2022
Surgical Gown, Blue, Sterile
K220665 · FYA
Excellent Medical Technology Group...
General Hospital · 88d
Cleared Jun 02, 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile...
K220547 · LZA
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 02, 2022
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile...
K220541 · LZA
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 02, 2022
Q2 IV Administration Sets
K213588 · FPA
Quest Medical, Inc.
General Hospital · 202d
Cleared Jun 01, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with...
K220488 · LZA
Anhui Zhong Lian Latex Gloves...
General Hospital · 99d
Cleared Jun 01, 2022
Purgo
K213753 · FRA
Aeroclean Technologies, LLC
General Hospital · 183d
Cleared Jun 01, 2022
freeflex+ Transfer Adapter
K212445 · LHI
Fresenius Kabi AG
General Hospital · 300d
Cleared May 31, 2022
Disposable Powder Free Polyethylene Examination Gloves
K212699 · LZA
Mastermax Plastic (Huizhou), Ltd.
General Hospital · 279d
Cleared May 28, 2022
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors,...
K213141 · LZA
Shen Wei (Usa), Inc.
General Hospital · 243d
Cleared May 28, 2022
Amazing+ Latex Examination Powder Free Gloves
K212597 · LYY
Amazing Rubber Products Pvt, Ltd.
General Hospital · 285d
Cleared May 28, 2022
Blue Nitrile Examination Gloves Powder Free
K212584 · LZA
Amazing Rubber Products Pvt, Ltd.
General Hospital · 285d
Cleared May 27, 2022
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs...
K220609 · LZA
Encompass Industries Sdn. Bhd.
General Hospital · 86d
Cleared May 26, 2022
Disposable Surgical Face Mask (FM-34EE,FM-44EE)
K220597 · FXX
Qingdao Bestex Rubber & Plastic...
General Hospital · 86d
Cleared May 26, 2022
Powder Free Nitrile Examination Gloves, Blue, Tested for use with...
K220545 · LZC
Hl Rubber Industries Sdn Bhd
General Hospital · 90d
Cleared May 26, 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With...
K220249 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 115d
Cleared May 26, 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K214074 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 150d
Cleared May 26, 2022
Aura Storm
K212644 · FRA
Invictus Lighting
General Hospital · 279d
Cleared May 26, 2022
PP Care Nitrile Examination Gloves
K212629 · LZA
Eg Group Product and Services Co., Ltd.
General Hospital · 280d
Cleared May 25, 2022
LDV((Low Dead Volume )Syringe
K220083 · QNQ
Anhui Hongyu Wuzhou Medical...
General Hospital · 135d
Cleared May 25, 2022
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
K213485 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 208d
Cleared May 25, 2022
Disposable Sterilized Latex Surgical Gloves
K211953 · KGO
Jiangxi Kemei Medical Apparatus &...
General Hospital · 336d
Cleared May 25, 2022
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
K210748 · FMI
W. L. Med Co., Ltd.
General Hospital · 439d