Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
1105–1128 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 24, 2022
The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant...
K211771 · FXX
The Good Corporation
General Hospital · 442d
Cleared Aug 23, 2022
Disposable Medical Safety Hypodermic Needle
K220603 · FMI
Hantech Medical Device Co., Ltd.
General Hospital · 174d
Cleared Aug 23, 2022
Safety Insulin Syringes
K220061 · MEG
Berpu Medical Technology Co., Ltd.
General Hospital · 225d
Cleared Aug 22, 2022
VPS Rhythm DLX Device with TipTracker Technology
K220363 · LJS
Arrow International, LLC (A...
General Hospital · 195d
Cleared Aug 22, 2022
SurGuard3 Safety Hypodermic Needle
K212095 · FMI
Terumo Europe N.V.
General Hospital · 412d
Cleared Aug 22, 2022
Powder Free Latex Examination Glove, Non-Sterile
K211601 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 455d
Cleared Aug 19, 2022
Lexa PLUS RIS-311
K213758 · FLE
W&H Sterilization S.R.L.
General Hospital · 262d
Cleared Aug 19, 2022
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
K212525 · LHI
Advcare Medical
General Hospital · 373d
Cleared Aug 19, 2022
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
K203078 · FXX
Huizhou Tianchang Industrial Co., Ltd.
General Hospital · 675d
Cleared Aug 18, 2022
Jeesung Safety Syringe and Single Use Needles
K212518 · MEG
Jeesung Medical Co., Ltd.
General Hospital · 373d
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