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
2137–2160 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 18, 2020
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with...
K201390 · LZC
Medline Industires, Inc.
General Hospital · 114d
Cleared Sep 18, 2020
Intellifuse Administration and Intellifuse Blood Administration Sets
K192375 · FPA
Smiths Medical Asd, Inc.
General Hospital · 385d
Cleared Sep 17, 2020
Single-Use Surgical Mask With Ear Loop
K201691 · FXX
Qiqihar Hengxin Medical Supplies, Ltd.
General Hospital · 87d
Cleared Sep 16, 2020
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential...
K201774 · KGO
Pt. Medisafe Technologies
General Hospital · 79d
Cleared Sep 11, 2020
TK Insulin Syringe with/without Saftey Retractable Device
K191639 · MEG
Anhui Tiankang Medical Technology...
General Hospital · 450d
Cleared Sep 10, 2020
Disposable Vinyl Glove
K202008 · LYZ
Best Care Trading Co., Ltd.
General Hospital · 51d
Cleared Sep 09, 2020
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
K201829 · KGO
Medline Industries, Inc.
General Hospital · 69d
Cleared Sep 09, 2020
Blood Collection Needle with/without Holder, Safety Blood Collection Needle...
K200027 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 247d
Cleared Sep 09, 2020
Benesta Hysteroscope
K192822 · HIH
Caldera Medical, Inc.
General Hospital · 344d
Cleared Sep 08, 2020
Surgical Mask-Model Number CW01
K202354 · FXX
Hunan Heng Chang Pharmaceutical Co.,...
General Hospital · 20d
Cleared Sep 08, 2020
Disposable Medical Face Mask
K201470 · FXX
Jkh USA, LLC
General Hospital · 97d
Cleared Sep 04, 2020
Protective Face Mask for Medical Use
K201537 · FXX
Shandong Shengquan New Material Co.,...
General Hospital · 88d
Cleared Sep 04, 2020
Plain Surgical Mask
K201517 · FXX
Aok Tooling Limited
General Hospital · 88d
Cleared Sep 04, 2020
BD Syringe NRFit Lok and BD Syringe NRFit Slip
K192538 · QEH
Becton, Dickinson and Company
General Hospital · 354d
Cleared Sep 03, 2020
Biodegradable Nitrile Examination Powder Free Glove, Green
K192111 · LZA
Top Glove Sdn. Bhd.
General Hospital · 395d
Cleared Sep 01, 2020
Endoscope Reprocessor OER-Elite
K201920 · FEB
Olympus Medical Systems Corp.
General Hospital · 53d
Cleared Aug 26, 2020
Motex Anti-Fog Surgical Face Mask
K201549 · FXX
Modern Healthcare Corp.
General Hospital · 78d
Cleared Aug 26, 2020
Single-use Surgical Mask
K200923 · FXX
Byd Precision Manufacturer Co., Ltd.
General Hospital · 141d
Cleared Aug 26, 2020
Deltaven Fast Flash Closed I.V. Catheter Systems
K200373 · FOZ
Delta Med Spa
General Hospital · 194d
Cleared Aug 26, 2020
TK Intravascular Administration Set
K191640 · FPA
Anhui Tiankang Medical Technology...
General Hospital · 434d
Cleared Aug 25, 2020
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim...
K201772 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 57d
Cleared Aug 25, 2020
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
K193338 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 267d
Cleared Aug 25, 2020
Injection Pen Needle
K192464 · FMI
Gangan Medical Technology Jiangsu...
General Hospital · 351d
Cleared Aug 20, 2020
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use...
K200093 · LZA
Anhui Lntco Medical Products Co., Ltd.
General Hospital · 217d