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
2065–2088 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 17, 2020
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
K203004 · DXT
Acist Medical Systems, Inc.
General Hospital · 77d
Cleared Dec 17, 2020
S dispensing line
K192770 · FMF
Aea Srl
General Hospital · 444d
Cleared Dec 16, 2020
Medical Surgical Mask
K202029 · FXX
Beijing Biosis Healing Biolog Ical...
General Hospital · 147d
Cleared Dec 16, 2020
NRFit® Caps, Male and Female Neuraxial Tip Caps
K201031 · QEH
International Medical Industries, Inc.
General Hospital · 240d
Cleared Dec 14, 2020
Medical Face Mask
K201629 · FXX
Shandong Shengquan New Material Co.,...
General Hospital · 181d
Cleared Dec 14, 2020
Sterile Hypodermic Syringe for Single Use, with/without needle,...
K201284 · FMF
Set Medikal Sanayi VE Ticaret Anonim...
General Hospital · 215d
Cleared Dec 11, 2020
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K203458 · JOJ
3M Company
General Hospital · 17d
Cleared Dec 11, 2020
3M Attest Rapid Readout Biological Indicator
K200996 · FRC
3M Company
General Hospital · 239d
Cleared Dec 10, 2020
3M Comply Hydrogen Peroxide Indicator Tape 1228
K203285 · JOJ
3M Company
General Hospital · 31d
Cleared Dec 09, 2020
Disposable Surgical Mask
K201893 · FXX
Xiamen Probtain Medical Techology...
General Hospital · 154d
Cleared Dec 09, 2020
Mini Spike Plus 6/8R
K201469 · LHI
B.Braun Medical, Inc.
General Hospital · 189d
Cleared Dec 09, 2020
Infrared Body Thermometer
K200781 · FLL
Heitaida Technology Co., Ltd.
General Hospital · 273d
Cleared Dec 08, 2020
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K202661 · FDT
Olympus Medical Systems Corp.
General Hospital · 85d
Cleared Dec 07, 2020
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
K203284 · QKM
3M Company
General Hospital · 28d
Cleared Dec 07, 2020
YUWELL Infrared Thermometer
K201864 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 154d
Cleared Dec 03, 2020
TempTraq
K201977 · FLL
Blue Spark Technologies, Inc.
General Hospital · 140d
Cleared Dec 03, 2020
Medical Mask
K201729 · FXX
Zhende Medical Co., Ltd.
General Hospital · 162d
Cleared Dec 02, 2020
WAVICIDE-OPA MEC Indicator
K202565 · JOJ
Serim Research Corporation
General Hospital · 89d
Cleared Dec 02, 2020
Palm Care Blue Nitrile Examination Gloves Powder Free
K202384 · LZA
Hi-Care Thai Gloves Co. , Ltd.
General Hospital · 104d
Cleared Dec 02, 2020
EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
K202270 · KCT
K1 Medical, LLC
General Hospital · 113d
Cleared Dec 01, 2020
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP...
K203199 · NVE
STERIS Corporation
General Hospital · 33d
Cleared Dec 01, 2020
Palm Care Latex Examination Powder Free Gloves
K202377 · LYY
Hi-Care Thai Gloves Co. , Ltd.
General Hospital · 103d
Cleared Dec 01, 2020
BASE4 Disposable Medical Mask
K202069 · FXX
Base4 Group, Inc.
General Hospital · 127d
Cleared Nov 30, 2020
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy...
K202416 · LZA
Kimberly Clark Corporation
General Hospital · 98d