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
1225–1248 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 16, 2022
STERRAD NX with ALLClear Technology
K220404 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 91d
Cleared May 16, 2022
AAMI3 Isolation Gown
K213832 · FYC
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 158d
Cleared May 16, 2022
Clicky Cross
K210516 · FMG
Yomura Technologies, Inc.
General Hospital · 447d
Cleared May 14, 2022
Introcan Safety IV Catheter
K220626 · FOZ
B.Braun Medical, Inc.
General Hospital · 71d
Cleared May 14, 2022
Disposable Medical Nitrile Examination Gloves -Tested for Use with...
K220491 · LZC
Hainan Asther Medical Equipment Co.,...
General Hospital · 81d
Cleared May 13, 2022
Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
K220749 · FXX
Unimax Medical Products Co., Ltd.
General Hospital · 60d
Cleared May 13, 2022
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220429 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 87d
Cleared May 13, 2022
Sterile Safety Hypodermic Needles for Single Use
K213535 · FMI
Zhejiang Kangkang Medical-Devices...
General Hospital · 189d
Cleared May 13, 2022
Provena(TM) Midline Catheter
K213203 · PND
C.R. Bard, Inc.
General Hospital · 226d
Cleared May 12, 2022
Synguard Nitrile Exam Glove
K220442 · LZA
Tianjin Aoshang Outdoor Equipment...
General Hospital · 85d
Cleared May 12, 2022
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free...
K220118 · LZA
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 118d
Cleared May 12, 2022
Sterile Hypodermic Syringes for Single Use
K213811 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 156d
Cleared May 12, 2022
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
K210937 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 409d
Cleared May 11, 2022
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K220250 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared May 11, 2022
Plus Medical Cover Gown
K213177 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 225d
Cleared May 11, 2022
Procedure Mask, Surgical Mask
K213001 · FXX
A Plus International, Inc.
General Hospital · 233d
Cleared May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220428 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220427 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
Needle Free Connector
K213004 · FPA
Medcaptain Life Science Co., Ltd.
General Hospital · 232d
Cleared May 06, 2022
Medline Orbis Chemo Surgical Gown
K214108 · FYA
Medline Industries, LP
General Hospital · 128d
Cleared May 05, 2022
Steriking Packaging for Medical Devices
K221016 · FRG
Wipak OY
General Hospital · 30d
Cleared May 05, 2022
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
K212346 · FLL
Shenzhen Pango Medical Electronics...
General Hospital · 281d
Cleared May 05, 2022
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1,...
K210565 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 434d
Cleared May 04, 2022
HydroPICC 5F Dual Lumen Catheter
K213550 · LJS
Access Vascular, Inc.
General Hospital · 177d