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
1297–1320 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 14, 2022
Qitexio
K203738 · FMF
Medex
General Hospital · 447d
Cleared Mar 12, 2022
Disposable Medical Face Mask
K213806 · FXX
Xiantao Zhibo Nonwoven Products Co.,...
General Hospital · 96d
Cleared Mar 11, 2022
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic...
K212920 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 178d
Cleared Mar 11, 2022
Maxima Surgical Gown
K201351 · FYA
Elevate Textiles
General Hospital · 659d
Cleared Mar 10, 2022
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K220361 · NZA
STERIS Corporation
General Hospital · 30d
Cleared Mar 10, 2022
Sterilization Wraps
K220133 · FRG
Weihai Hongyu Nonwoven Fabric...
General Hospital · 51d
Cleared Mar 10, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use with...
K213910 · LZC
Changzhou Universal Medical Equipment...
General Hospital · 85d
Cleared Mar 10, 2022
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with...
K213373 · LZA
Smart Glove Corporation Sdn. Bhd.
General Hospital · 149d
Cleared Mar 10, 2022
Infrared Forehead Thermometer, model: HS-9802D
K213038 · FLL
Jiaxing Shangjia Intelligence...
General Hospital · 170d
Cleared Mar 10, 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for...
K212148 · LZA
Ansell Healthcare Products, LLC
General Hospital · 244d
Cleared Mar 09, 2022
Disposable Medical Nitrile gloves
K213851 · LZA
Guangdong Xingcan Brothers Medical...
General Hospital · 89d
Cleared Mar 09, 2022
BD Insulin Syringe (0.3mL)
K212499 · FMF
Becton, Dickinson and Company
General Hospital · 212d
Cleared Mar 08, 2022
Medical Face Mask
K214087 · FXX
Hubei Medlink Healthcare Co., Ltd.
General Hospital · 71d
Cleared Mar 04, 2022
Surgical Gown
K213703 · FYA
Wujiang Tutaike Textiles & Finishing...
General Hospital · 100d
Cleared Mar 04, 2022
Surgical Mask
K213358 · FXX
Shenzhen Safesecure Medical Infection...
General Hospital · 143d
Cleared Mar 04, 2022
Surgical Trays
K212281 · KCT
Dentsply Sirona, Inc.
General Hospital · 226d
Cleared Mar 04, 2022
Medcare Powder-Free Blue Nitrile Patient Examination Gloves
K211808 · LZA
Dongguan Grinvald Technology Co., Ltd.
General Hospital · 266d
Cleared Mar 04, 2022
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use...
K210330 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 393d
Cleared Mar 04, 2022
Disposable Automatically Retractable Insulin Safety Syringe
K210216 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 401d
Cleared Mar 03, 2022
IV Administration Set
K213778 · FPA
B.Braun Medical, Inc.
General Hospital · 90d
Cleared Mar 02, 2022
Giraffe Incubator Carestation CS1
K213553 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 114d
Cleared Mar 02, 2022
Giraffe Omnibed Carestation CS1
K213551 · FMT
Datex-Ohmeda, Inc.
General Hospital · 114d
Cleared Mar 02, 2022
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance...
K213457 · FLE
Fort Defiance Industries, LLC
General Hospital · 126d
Cleared Mar 02, 2022
Plus Medical Isolation Gown Level 3
K212698 · FYC
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 189d