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
745–768 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared May 26, 2023
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
K213289 · KGO
Ansell Healthcare Products, LLC
General Hospital · 602d
Cleared May 25, 2023
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for...
K231169 · MLR
Plasmapp Co,., Ltd.
General Hospital · 30d
Cleared May 25, 2023
Nipro SafeTouch Needle
K222852 · FMI
Nipro Medical Corporation
General Hospital · 246d
Cleared May 23, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
K230564 · LZA
Central Medicare Sdn Bhd
General Hospital · 83d
Cleared May 22, 2023
MixJect® Transfer Device
K230464 · LHI
West Pharma Services Il, Ltd.
General Hospital · 90d
Cleared May 19, 2023
SafeBreak® Vascular
K223486 · QOI
Lineus Medical
General Hospital · 179d
Cleared May 19, 2023
Disposable Medical Mask
K222545 · FXX
Guangzhou Fuzelong Hygiene Material...
General Hospital · 270d
Cleared May 18, 2023
I.V. Administration Set, I.V. Extension Set
K223645 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 163d
Cleared May 18, 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · KKX
3M Company
General Hospital · 266d
Cleared May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with...
K223437 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 184d