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
2185–2208 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 20, 2020
Retractable Safety Insulin Syringe
K193022 · MEG
Jiangsu Caina Medical Co.,Ltd
General Hospital · 264d
Cleared Jul 20, 2020
Intravascular Extension Sets and Accessories
K192366 · FPA
Baxter Healthcare Corporation
General Hospital · 325d
Cleared Jul 17, 2020
Syringe with safety needle, Safety needle
K193526 · FMF
Jiangsu Caina Medical Co.,Ltd
General Hospital · 211d
Cleared Jul 16, 2020
Infrared Thermometer Model Number RN-50A,RN-50B
K200578 · FLL
Ningbo Ranor Medical Science &...
General Hospital · 133d
Cleared Jul 15, 2020
BD SoloShot Mini Syringe/ BD Auto Disable Syringe
K201234 · FMF
Becton, Dickinson and Company
General Hospital · 69d
Cleared Jul 15, 2020
iHealth Infrared No-Touch Forehead Thermometer
K200531 · FLL
Andon Health Co, Ltd.
General Hospital · 135d
Cleared Jul 13, 2020
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
K200960 · LZA
Medline Industires, Inc.
General Hospital · 94d
Cleared Jul 08, 2020
Digital Thermometer
K200599 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 121d
Cleared Jul 02, 2020
3M Attest Steam Chemical Integrator Test Pack
K200766 · FRC
3M Company
General Hospital · 99d
Cleared Jul 02, 2020
ulrichINJECT CT Motion
K192872 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 268d
Cleared Jul 02, 2020
ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor,...
K192385 · PMS
Ivwatch, LLC
General Hospital · 303d
Cleared Jun 30, 2020
Terragene Chemdye
K200272 · JOJ
Terragene S.A.
General Hospital · 147d
Cleared Jun 26, 2020
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne...
K200250 · FYD
Megadyne Medical Products, Inc.
General Hospital · 144d
Cleared Jun 19, 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue...
K200671 · LZA
Ansell Healthcare Products, LLC
General Hospital · 98d
Cleared Jun 19, 2020
Infrared Thermometer Model Number RN-60A,RN-60B
K200471 · FLL
Ningbo Ranor Medical Science &...
General Hospital · 114d
Cleared Jun 19, 2020
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs...
K192954 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 242d
Cleared Jun 19, 2020
STATClave G4 Chamber Autoclave
K192910 · FLE
Scican , Ltd.
General Hospital · 248d
Cleared Jun 18, 2020
InPen System
K201337 · NDC
Companion Medical, Inc.
General Hospital · 29d
Cleared Jun 17, 2020
Aerus Medical Guardian,model F170A
K201220 · FRA
Aerus Medical, LLC
General Hospital · 42d
Cleared Jun 17, 2020
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
K193253 · FLL
Shenzhen Changkun Technology Co., Ltd.
General Hospital · 212d
Cleared Jun 06, 2020
mCare(R) Powder Free Nitrile Orange Examination Gloves
K200967 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 57d
Cleared Jun 05, 2020
Latex Examination Powder Free Glove, Aloe Vera
K193150 · LZA
Top Glove Sdn. Bhd.
General Hospital · 205d
Cleared Jun 05, 2020
3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM...
K192550 · FRC
3M Company
General Hospital · 262d
Cleared Jun 04, 2020
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K193555 · LZC
Ever Global (Vietnam) Enterprise Corp
General Hospital · 167d