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
577–600 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 27, 2023
T-Top 10 & T-Top T-Top 11
K232658 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 88d
Cleared Nov 21, 2023
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant...
K233049 · PSW
Cs Medical, LLC
General Hospital · 57d
Cleared Nov 21, 2023
Medical Nitrile Examination Gloves
K232576 · LZA
Jiangsu Complete Sincerity Medical...
General Hospital · 88d
Cleared Nov 21, 2023
High Pressure Tubing
K232388 · DXT
Ningbo Dizegens Medical Science Co.,Ltd
General Hospital · 104d
Cleared Nov 21, 2023
SaviSafe Safety Device
K230287 · MEG
Suzhou Savicred Biotechnology Co., Ltd.
General Hospital · 292d
Cleared Nov 17, 2023
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR...
K232538 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 87d
Cleared Nov 14, 2023
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for...
K232461 · LZA
Kossan International Sdn Bhd
General Hospital · 91d
Cleared Nov 09, 2023
Flush Syringe (Prefilled 0.9% normal saline solution)
K231724 · NGT
Spm Medicare Pvt. , Ltd.
General Hospital · 149d
Cleared Nov 09, 2023
LILY Extension Tube and Needleless Connector
K222780 · FPA
Lily Medical Corporation
General Hospital · 421d
Cleared Nov 07, 2023
Biodegradable Medical surgical mask
K231155 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 197d
Cleared Nov 06, 2023
Revital Cady
K231519 · FMF
Revital Healthcare (Epz) Limited
General Hospital · 165d
Cleared Nov 03, 2023
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile,...
K232266 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 95d
Cleared Nov 03, 2023
Freedom60 Infusion Pump
K231918 · FRN
Koru Medical Systems
General Hospital · 127d
Cleared Nov 03, 2023
ProSeal™ Closed System Administration Set
K230343 · FPA
Epic Medical Pte. , Ltd.
General Hospital · 268d
Cleared Oct 31, 2023
Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
K231298 · PQM
Alesi Surgical, Ltd.
General Hospital · 180d
Cleared Oct 31, 2023
Ultravision2™ System
K231238 · PQM
Alesi Surgical, Ltd.
General Hospital · 186d
Cleared Oct 31, 2023
SAFIRA
K230083 · FRN
Medovate Limited
General Hospital · 293d
Cleared Oct 30, 2023
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
K231029 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 202d
Cleared Oct 27, 2023
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
K233187 · JOJ
Steris
General Hospital · 29d
Cleared Oct 27, 2023
Shina Syringe
K231165 · MEG
Shina Med Corporation
General Hospital · 185d
Cleared Oct 27, 2023
Safety butterfly type blood collection needle, Butterfly type blood...
K213146 · JKA
Jiangsu Rongye Technology Co., Ltd.
General Hospital · 760d
Cleared Oct 26, 2023
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs,...
K230662 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 230d
Cleared Oct 25, 2023
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · KKX
Avery Dennison Medical , Ltd.
General Hospital · 231d
Cleared Oct 23, 2023
Vesco Q™ Enteral Feeding Pump
K232205 · LZH
Vesco Medical, LLC
General Hospital · 90d