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
985–1008 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 04, 2022
Disposable Medical Face Mask (DF3-001)
K222697 · FXX
Wellmed Dental Medical Supply Co., Ltd.
General Hospital · 58d
Cleared Nov 04, 2022
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
K222124 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 109d
Cleared Nov 04, 2022
Medwell Technology Ltd Syringes, various sizes
K212764 · FMF
Medwell Technology, Ltd.
General Hospital · 430d
Cleared Nov 03, 2022
NP Medical nCompass Extension Set with Stabilizing Base
K221518 · FPA
Np Medical
General Hospital · 162d
Cleared Nov 03, 2022
Insulin Syringes without needle
K221045 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 209d
Cleared Nov 02, 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K223320 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 5d
Cleared Nov 02, 2022
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded...
K220371 · LZA
Summit Glove, Inc.
General Hospital · 266d
Cleared Nov 02, 2022
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for...
K211816 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 509d
Cleared Nov 01, 2022
POSE™ Health Care Surgical Mask
K223270 · FXX
America?S Supply Chains
General Hospital · 8d
Cleared Nov 01, 2022
3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
K222508 · JOJ
3M Company
General Hospital · 75d
Cleared Nov 01, 2022
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe...
K221247 · MEG
Jiangsu Kangbao Medical Equipment...
General Hospital · 183d
Cleared Oct 31, 2022
IO Needle Safety Sheath
K220890 · FMI
Actuated Medical, Inc.
General Hospital · 217d
Cleared Oct 28, 2022
Non Sterile Powder Free Latex Examination Glove
K221667 · LYY
New Era Medicare Sdn. Bhd.
General Hospital · 142d
Cleared Oct 28, 2022
Vented Vial Transfer Pin
K221406 · LHI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 165d
Cleared Oct 28, 2022
Disposable Surgical Gown Rk-3011C
K211060 · FYA
Xiantao Rhycom Non-Woven Products...
General Hospital · 567d
Cleared Oct 27, 2022
S.I.N. Instrument Kits
K222514 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 69d
Cleared Oct 27, 2022
JR MEDIC
K222348 · LYY
Jr Engineering & Medical Technologies...
General Hospital · 85d
Cleared Oct 26, 2022
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
K223235 · LZA
Pt. Sintong Unigolden Glove
General Hospital · 13d
Cleared Oct 26, 2022
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
K222498 · LZA
Humanwell Healthcare Group Medical...
General Hospital · 69d
Cleared Oct 26, 2022
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
K221374 · LYY
Hebei Titans Hongsen Medical...
General Hospital · 167d
Cleared Oct 26, 2022
Eclipse Blood Collection Set
K213690 · JKA
Eclipse Medcorp, LLC
General Hospital · 337d
Cleared Oct 25, 2022
JR MEDIC Nitrile Examination Gloves Powder Free- Black
K221169 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 186d
Cleared Oct 25, 2022
Disposable Surgical Face Mask
K212649 · FXX
Lyncmed Medical Technology (Beijing)...
General Hospital · 428d
Cleared Oct 22, 2022
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with...
K222058 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 102d