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
1057–1080 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 30, 2022
Medical Surgery Mask, Model:2626-7
K220067 · FXX
Dongguan Missadola Technology Co., Ltd.
General Hospital · 232d
Cleared Aug 30, 2022
SOL-GUARD Safety Pull Button Collection Set
K213718 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 279d
Cleared Aug 30, 2022
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile...
K212846 · FMF
Jiangsu Jichun Medical Devices Co., Ltd.
General Hospital · 357d
Cleared Aug 30, 2022
Novum IQ Syringe Pump
K211125 · FRN
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Dose IQ Safety Software
K211124 · PHC
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 29, 2022
K-SHIELD Zen
K220799 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 164d
Cleared Aug 29, 2022
Leaderflex Mini and Leaderflex Nano
K212370 · FOZ
Vygon USA
General Hospital · 395d
Cleared Aug 27, 2022
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy...
K222449 · LZC
Better Care Plastic Technology Co., Ltd.
General Hospital · 12d
Cleared Aug 25, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222543 · NVE
Steris
General Hospital · 3d
Cleared Aug 25, 2022
Iconic Latex Glove
K221648 · LYY
Iconic Medicare Sdn Bhd
General Hospital · 79d
Cleared Aug 25, 2022
Nitrile Exam Gloves (Blue, Black)
K221143 · LZA
Hebei Astro Medical Supply Co., Ltd.
General Hospital · 127d
Cleared Aug 25, 2022
Disposable, vinyl examination gloves, Yellow
K220055 · LYZ
Dezhou Hengchang Medical Technology...
General Hospital · 231d
Cleared Aug 24, 2022
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
K222232 · LJS
Bard Access Systems, Inc.
General Hospital · 30d
Cleared Aug 24, 2022
ivWatch Model 400
K222212 · PMS
Ivwatch, LLC
General Hospital · 30d
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