FDA 510(k) Applications Submitted by Max li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K241064 |
04/18/2024 |
Unscented Tampon |
Shandong Intco Hygiene Products Co., Ltd. |
| K231365 |
05/11/2023 |
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves |
Anhui Intco Medical Products Co., Ltd |
| K231408 |
05/15/2023 |
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile |
Shandong Intco Medical Products Co, Ltd. |
| K232252 |
07/28/2023 |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) |
Dehai (Shandong) Medical Gloves, Co., Ltd. |
| K202708 |
09/16/2020 |
Surgical Face Masks |
Intco Medical(HK) Co., Ltd. |
| K233042 |
09/25/2023 |
Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Shandong Intco Medical Products Co, Ltd. |
| K233598 |
11/09/2023 |
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs |
Anhui Intco Medical Products Co., Ltd. |
| K000976 |
03/27/2000 |
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) |
INSTRUMENTARIUM IMAGING, INC. |
| K001171 |
04/11/2000 |
DELTA 16 TACT |
INSTRUMENTARIUM IMAGING, INC. |
| K981641 |
05/08/1998 |
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ |
INSTRUMENTARIUM CORP. |
| K230817 |
03/24/2023 |
TORPEDO Implant System« |
Deltacor GmbH |
| K223180 |
10/11/2022 |
AIRAscore |
AIRAmed GmbH |
| K223254 |
10/21/2022 |
C2 Xplore |
Inomed Medizintechnik GmbH |
| K103555 |
12/03/2010 |
MULTIPLATE 5.0 AGGREGOMETER |
VERUM DIAGNOSTICA GMBH |
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