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
769–792 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 14, 2023
Synexis Sphere Rx
K221540 · FRA
Synexis, LLC
General Hospital · 383d
Cleared Jun 13, 2023
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with...
K230573 · LYY
Kossan International Sdn Bhd
General Hospital · 104d
Cleared Jun 12, 2023
SecurePortIV Advanced Catheter Securement Adhesive
K223669 · NZP
Adhezion Biomedical, LLC
General Hospital · 187d
Cleared Jun 09, 2023
DJF Intravascular Administration Set
K230992 · FPA
Yangzhou Wei DE LI Trade Co., Ltd.
General Hospital · 64d
Cleared Jun 09, 2023
Powder Free Nitrile Examination Gloves (Black), Tested for Use with...
K230779 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 80d
Cleared Jun 08, 2023
Promisemed Safety Huber Needle
K230715 · PTI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 85d
Cleared Jun 07, 2023
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide...
K230381 · PSW
Cs Medical, LLC
General Hospital · 114d
Cleared Jun 07, 2023
Infrared Thermometer
K222248 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 316d
Cleared Jun 06, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With...
K231349 · LZA
Nephron Nitrile, LLC
General Hospital · 28d
Cleared Jun 05, 2023
APOLLO ADVANTAGE Nitrile Examination Gloves
K230633 · LZA
Dell Corning Corporation
General Hospital · 90d
Cleared Jun 05, 2023
Fluido Compact Blood and Fluid Warming System
K211618 · LGZ
The Surgical Company International B.V.
General Hospital · 740d
Cleared Jun 02, 2023
Pen Needle
K230635 · FMI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 87d
Cleared Jun 02, 2023
RGS
K222702 · FRA
Genesis Air, Inc.
General Hospital · 268d
Cleared Jun 02, 2023
Volumat Line
K220301 · FPA
Fresenius Kabi
General Hospital · 485d
Not Cleared Jun 02, 2023
Tristel Duo ULT
DEN220041 · QWS
Tristel Solutions Limited
General Hospital · 338d
Cleared Jun 01, 2023
Surgical Face Mask (L 175*95mm)
K230617 · FXX
Henan Chaoya Medical Equipment Co., Ltd.
General Hospital · 87d
Cleared Jun 01, 2023
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
K230408 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 106d
Cleared Jun 01, 2023
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps...
K222905 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 251d
Cleared May 31, 2023
Disposable Nitrile Gloves (ABC-DG01)
K230542 · LZA
Huizhou Anboson Technology Co., Ltd.
General Hospital · 92d
Cleared May 31, 2023
FEELject LDV (Low dead volume) syringe
K213010 · QNQ
Feeltech Co., Ltd.
General Hospital · 618d
Cleared May 30, 2023
First Glove Blue Nitrile Examination Gloves Powder Free
K230958 · LZA
First Glove Sdn. Bhd.
General Hospital · 56d
Cleared May 30, 2023
Babyroo TN300
K230278 · FMT
Draeger Medical Systems, Inc.
General Hospital · 118d
Cleared May 28, 2023
Blue Nitrile Examination Gloves Powder Free
K230601 · LZA
Latrile Gloves Private Limited
General Hospital · 86d
Cleared May 26, 2023
Sweden & Martina Surgical Trays
K222640 · KCT
Sweden & Martina S.P.A.
General Hospital · 267d