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
2305–2328 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 03, 2020
PiccGuard
K191195 · PZW
Piccguard, LLC
General Hospital · 245d
Cleared Dec 31, 2019
mCare® Powder Free Nitrile Black Examination Glove
K192444 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 116d
Cleared Dec 31, 2019
Digital Thermometer
K190990 · FLL
Xiamen Ants Bro Technology Co., Ltd.
General Hospital · 260d
Cleared Dec 30, 2019
Sterile Latex Surgical Glove, Powder Free
K190241 · KGO
Careglove Global Sdn. Bhd.
General Hospital · 327d
Cleared Dec 23, 2019
3M Attest Steam Chemical Integrator
K193254 · JOJ
3M Company
General Hospital · 27d
Cleared Dec 23, 2019
EZ-TRAX Containment Device
K192487 · KCT
K1 Medical, LLC
General Hospital · 103d
Cleared Dec 23, 2019
Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use...
K192104 · LZA
Medline Industries, Inc.
General Hospital · 140d
Cleared Dec 23, 2019
Disposable Powder Free Nitrile Examination Glove, Tested For Use With...
K190860 · LZA
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 265d
Cleared Dec 23, 2019
Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use...
K190736 · LZA
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 277d
Cleared Dec 23, 2019
Neodent Instrument Kit Cases
K190665 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 283d
Cleared Dec 19, 2019
TK Sterile Hypodermic Needle
K191643 · FMI
Anhui Tiankang Medical Technology...
General Hospital · 183d
Cleared Dec 18, 2019
Neodent Instrument Kit Cases
K192670 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 84d
Cleared Dec 18, 2019
Sterile Latex Powder-Free Surgical Gloves
K191898 · KGO
Modern Healthcare Corp.
General Hospital · 155d
Cleared Dec 17, 2019
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs...
K190725 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 272d
Cleared Dec 13, 2019
neria guard Infusion Set
K192647 · FPA
Unomedical A/S
General Hospital · 80d
Cleared Dec 13, 2019
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K192370 · DXT
Bayer Medical Care, Inc.
General Hospital · 105d
Cleared Dec 13, 2019
Aero Blue Performance Surgical Gowns
K192362 · FYA
O&M Halyard, Inc.
General Hospital · 105d
Cleared Dec 13, 2019
Infrared Thermometer, model: PC808
K190717 · FLL
Shenzhen Pacom Medical Instruments...
General Hospital · 268d
Cleared Dec 10, 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K192929 · MED
STERIS Corporation
General Hospital · 54d
Cleared Dec 10, 2019
Health Line CT CVC
K192533 · FOZ
Health Line International Corporation
General Hospital · 85d
Cleared Dec 05, 2019
MEDRAD Mark 7 Arterion Injection System
K193028 · DXT
Bayer Medical Care, Inc.
General Hospital · 36d
Cleared Dec 03, 2019
Straumann Modular Cassette
K191522 · KCT
Institut Straumann AG
General Hospital · 176d
Cleared Dec 02, 2019
Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
K192374 · FXX
Cardinal Health200, LLC
General Hospital · 94d
Cleared Dec 02, 2019
mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs...
K190876 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 242d