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
1489–1512 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 06, 2021
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with...
K212827 · LZC
Jr Engineering & Medical Technologies...
General Hospital · 94d
Cleared Dec 06, 2021
Surgical Face Mask
K212235 · FXX
Shanghai Yunqing Industrial Co., Ltd.
General Hospital · 140d
Cleared Dec 06, 2021
PMW01 Procedure Mask Level 1
K211772 · FXX
Defender Safety, Inc.
General Hospital · 181d
Cleared Dec 04, 2021
Nitrile Powder Free Blue Examination Gloves, Non-Sterile
K212535 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 115d
Cleared Dec 03, 2021
Surgical Masks
K212807 · FXX
Weihai Hongyu Nonwoven Fabric...
General Hospital · 91d
Cleared Dec 02, 2021
powder free nitrile examination glove - white, non-sterile
K212802 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 91d
Cleared Dec 02, 2021
Puravita Medical Fold Flat Surgical Mask
K212740 · FXX
Puravita M, LLC
General Hospital · 94d
Cleared Dec 02, 2021
Nitrile disposable examination gloves
K212578 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 108d
Cleared Dec 02, 2021
Single-use Surgical Mask
K211773 · FXX
Taiwan Seafood and Fish Corporation
General Hospital · 177d
Cleared Dec 01, 2021
Powder free nitrile examination glove- blue, non-sterile
K212804 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 90d
Cleared Dec 01, 2021
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212789 · LZA
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 91d
Cleared Nov 30, 2021
Disposable Surgical Face Mask
K211696 · FXX
Anhui Cleanpro Pharmpack Co., Ltd.
General Hospital · 181d
Cleared Nov 30, 2021
InstruSafe Instrument Protection System
K210836 · KCT
Summitt Medical, LLC
General Hospital · 253d
Cleared Nov 26, 2021
Nitrile Examination Gloves
K212722 · LZA
Wuhan Huirui Technology Co., Ltd.
General Hospital · 91d
Cleared Nov 26, 2021
Synthetic Nitrile Examination Gloves
K212488 · LYZ
Shandong Hongxin Chemicals Co., Ltd.
General Hospital · 109d
Cleared Nov 26, 2021
CUBE Air Purifier
K211139 · FRA
Samsung Electronics Co., Ltd.
General Hospital · 224d
Cleared Nov 26, 2021
Medical surgical mask
K202842 · FXX
Henan Huibo Medical Co., Ltd.
General Hospital · 427d
Cleared Nov 24, 2021
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown -...
K212633 · FYC
String King Lacrosse, LLC
General Hospital · 97d
Cleared Nov 24, 2021
Non-Contact Infrared Thermometer, model HL710H
K211744 · FLL
Health & Life Co., Ltd.
General Hospital · 170d
Cleared Nov 24, 2021
Surgical Mask (sterile)
K211295 · FXX
Nanjing 3h Medical Products Co., Ltd.
General Hospital · 210d
Cleared Nov 23, 2021
039 Surgical Face Mask
K211956 · FXX
Aok Tooling Limited
General Hospital · 152d
Cleared Nov 23, 2021
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub...
K211765 · FYA
Cardinal Health, LLC
General Hospital · 168d
Cleared Nov 23, 2021
PCEA Syringe Set
K211649 · PWH
Baxter Healthcare Corporation
General Hospital · 179d
Cleared Nov 22, 2021
Non-sterile Powder Free Nitrile Examination Gloves
K210990 · LZA
Rubberex Alliance Sdn Bhd
General Hospital · 234d