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
1081–1104 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 17, 2022
Surgical Face Mask (HNFM0103)
K221838 · FXX
Shanghai Hua EN Industrial Co, Ltd.
General Hospital · 55d
Cleared Aug 17, 2022
Cross Protection ResQ300 Plus Surgical Face Mask
K212273 · FXX
Cross Protection (M) Sdn Bhd
General Hospital · 393d
Cleared Aug 17, 2022
Disposable Sterile Syringe, with/without needle
K212033 · FMF
Shandong Zhushi Pharmaceutical Group...
General Hospital · 414d
Cleared Aug 16, 2022
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves...
K213937 · LZA
O&M Halyard, Inc.
General Hospital · 243d
Cleared Aug 12, 2022
Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
K221027 · FYC
Allmed Medical (Hubei) Protective...
General Hospital · 128d
Cleared Aug 12, 2022
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion...
K202461 · LGZ
Smisson-Cartledge Biomedical, LLC
General Hospital · 715d
Cleared Aug 10, 2022
Safety Blood Collection Needles with/without Needle Holder
K220900 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 135d
Cleared Aug 09, 2022
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue,...
K212482 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 365d
Cleared Aug 06, 2022
Pro Guard Nitrile Powder Free Examination Glove
K213934 · LZA
Medical Glove Co., Ltd.
General Hospital · 233d
Cleared Aug 05, 2022
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with...
K221350 · LZA
Rubberex Alliance Products Sdn Bhd
General Hospital · 87d
Cleared Aug 05, 2022
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
K213993 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 227d
Cleared Aug 03, 2022
Solidence Multipockets
K191131 · FRG
Solidence Surgical Corporation
General Hospital · 1192d
Cleared Aug 01, 2022
Consolidated HC Steam Sterilizer
K220736 · FLE
Consolidated Machine Corp.
General Hospital · 140d
Cleared Aug 01, 2022
Disposable Medical Nitrile Examination Gloves
K220237 · LZA
Fujian Jixiang Medical Technology...
General Hospital · 186d
Cleared Aug 01, 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with...
K213929 · LZA
O&M Halyard, Inc.
General Hospital · 228d
Cleared Jul 30, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For...
K221773 · LZA
Onetexx Sdn Bhd
General Hospital · 39d
Cleared Jul 29, 2022
EleGARD
K221901 · FOA
Advancedcpr Solutions, LLC
General Hospital · 29d
Cleared Jul 27, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with...
K221271 · LZA
Shandong Maida Medical Technology...
General Hospital · 86d
Cleared Jul 27, 2022
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with...
K221269 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 86d
Cleared Jul 27, 2022
AOK 95A Medical Mask (20200049)
K220876 · FXX
Aok Tooling Limited
General Hospital · 124d
Cleared Jul 27, 2022
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
K214007 · FRG
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 217d
Cleared Jul 25, 2022
Paneffort 3-ply Surgical and Procedural Masks
K221409 · FXX
Paneffort, LLC
General Hospital · 70d
Cleared Jul 23, 2022
Powder-Free Nitrile Examination Glove, Non-Sterile
K221877 · LZA
Goodgloves Industries Sdn Bhd
General Hospital · 25d
Cleared Jul 22, 2022
Disposable Medical Face Mask (ear loop)
K221196 · FXX
Xiantao Topmed Nonwoven Protective...
General Hospital · 88d