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
697–720 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 24, 2023
Plum Duo™ Infusion System
K223607 · FRN
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 24, 2023
LifeShield™ Infusion Safety Software Suite
K223606 · PHC
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 24, 2023
Nitrile Patient Examination Gloves, Powder Free, Pink Color
K222103 · LZA
Shandong Yinghng Medical Products...
General Hospital · 402d
Cleared Aug 23, 2023
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown...
K230610 · FYA
Dongguan Shin YI Healthcare Products...
General Hospital · 170d
Cleared Aug 23, 2023
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low...
K230079 · KGO
Ansell Healthcare Products, LLC
General Hospital · 225d
Cleared Aug 22, 2023
Surgical Gown (S,M,L,XL,XXL,XXXL)
K231510 · FYA
Xiantao Zhibo Non-Woven Products Co.,...
General Hospital · 89d
Cleared Aug 18, 2023
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim,...
K222993 · KGO
Sentienx Sdn Bhd
General Hospital · 324d
Cleared Aug 16, 2023
Guided Surgery Kit
K231087 · DZI
Implant Direct Sybron Manufacturing, LLC
General Hospital · 121d
Cleared Aug 16, 2023
Powdered Free Sterile Natural Rubber Latex Surgical Gloves
K230832 · KGO
The Egyptian Company For Medical &...
General Hospital · 142d
Cleared Aug 16, 2023
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
K230577 · FYA
Medcare Saglik Urunleri Sanayi VE...
General Hospital · 168d
Cleared Aug 16, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
K230314 · LZA
New Era Medicare Sdn. Bhd.
General Hospital · 191d
Cleared Aug 16, 2023
Celsi Monitor
K230298 · FLL
Hadleigh Health Technologies
General Hospital · 195d
Cleared Aug 12, 2023
TK Pre-Filled Normal Saline Flush Syringe
K230756 · NGT
Anhui Tiankang Medical Technology...
General Hospital · 145d
Cleared Aug 12, 2023
Pre-Filled Normal Saline Flush Syringe
K223584 · NGT
Anhui Tianyang Pharmaceutical Co., Ltd.
General Hospital · 254d
Cleared Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
K231439 · LZA
S&S Glove Corporation
General Hospital · 86d
Cleared Aug 11, 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
K231408 · LZA
Shandong Intco Medical Products Co, Ltd.
General Hospital · 88d
Cleared Aug 11, 2023
PolyWear® Personal Protective Level 3 Gown
K230384 · QPC
PolyConversions, Inc.
General Hospital · 178d
Cleared Aug 09, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K232039 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 30d
Cleared Aug 09, 2023
Polyisoprene Surgical Gloves
K230304 · KGO
Puyang Linshi Medical Supplies Co., Ltd.
General Hospital · 187d
Cleared Aug 08, 2023
Disposable Medical Examination Nitrile Gloves
K232008 · LZA
Raxwell Industrial, LLC
General Hospital · 33d
Cleared Aug 08, 2023
Protective Gown AAMI Level 4
K222128 · QPC
Kenpax International Limited
General Hospital · 386d
Cleared Aug 07, 2023
PRO-LITE Sterilization Tray
K231501 · KCT
STERIS Corporation
General Hospital · 75d
Cleared Aug 07, 2023
Vis-U-All Low Temperature Sterilization Pouches
K231500 · FRG
STERIS Corporation
General Hospital · 75d
Cleared Aug 07, 2023
Celerity 20 HP Biological Indicator
K231490 · FRC
STERIS Corporation
General Hospital · 76d