Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
2425–2448 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 11, 2019
3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure...
K191355 · FXX
3M Healthcare
General Hospital · 113d
Cleared Sep 09, 2019
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT...
K183444 · LDS
Cenorin, LLC
General Hospital · 271d
Cleared Sep 06, 2019
Sure-Fine Insulin Syringes
K191531 · FMF
Shina Med Corporation
General Hospital · 88d
Cleared Sep 06, 2019
Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With...
K190403 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 199d
Cleared Sep 06, 2019
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile...
K183665 · MEG
Jiangsu Micsafe Medical Technology...
General Hospital · 253d
Cleared Sep 06, 2019
Reusable Temperature Probe
K182751 · FLL
Shenzhen Caremed Medical Technology...
General Hospital · 343d
Cleared Sep 05, 2019
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator...
K192020 · JOJ
STERIS Corporation
General Hospital · 38d
Cleared Sep 05, 2019
Dual-Safety Pen Needle
K191853 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 57d
Cleared Sep 05, 2019
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
K191343 · MED
STERIS Corporation
General Hospital · 108d
Cleared Sep 05, 2019
Advocate Non-Contact Infrared Thermometer
K191004 · FLL
Broadmaster Biotech, Corp.
General Hospital · 142d
Cleared Sep 05, 2019
bili-hut
K190899 · LBI
Little Sparrows Technologies, Inc.
General Hospital · 150d
Cleared Sep 03, 2019
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc...
K182765 · FMF
Top Corporation
General Hospital · 340d
Cleared Aug 29, 2019
EvaQMax Smoke Evacuation System
K192035 · FYD
Bio Protech, Inc.
General Hospital · 30d
Cleared Aug 29, 2019
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic...
K191475 · KCT
Nobel Biocare AB
General Hospital · 86d
Cleared Aug 29, 2019
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination...
K182382 · LZC
Gmp Medicare Sdn Bhd (F25)
General Hospital · 363d
Cleared Aug 21, 2019
RAS 12 Rack, RAS 12 Long Rack
K190081 · NVE
STERIS Corporation
General Hospital · 217d
Cleared Aug 19, 2019
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical...
K183356 · FRG
Weihai Xingtai Packaging Products...
General Hospital · 258d
Cleared Aug 16, 2019
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K183536 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 240d
Cleared Aug 15, 2019
HCT Empty EVA Container Pack
K190328 · KPE
Health Care Technologies
General Hospital · 183d
Cleared Aug 02, 2019
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization...
K191741 · JOJ
Intertape Polymer, Inc.
General Hospital · 32d
Cleared Aug 02, 2019
PowerFlow Implantable Apheresis IV Port
K191143 · PTD
C.R. Bard, Inc.
General Hospital · 94d
Cleared Jul 30, 2019
Powder Free Blue Nitrile Examination Gloves - Tested for Use with...
K182089 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 362d
Cleared Jul 30, 2019
Blood Collection Accessory (BUCA)
K181754 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 393d
Cleared Jul 30, 2019
Blood Transfer Accessory (BTA)
K181743 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 393d