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
2569–2592 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 14, 2018
SporView Rapid Read Biological Indicator SteamPlus Test Pack
K181434 · FRC
Crosstex/Spsmedical, A Division of...
General Hospital · 166d
Cleared Nov 13, 2018
Immucise Intradermal Injection System
K181369 · FMI
Terumo Corporation
General Hospital · 174d
Cleared Nov 09, 2018
EZ-IO Intraosseous Vascular Access System
K180395 · FMI
Arrow International, Inc. (Subsidiary...
General Hospital · 269d
Cleared Nov 08, 2018
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K180047 · FLL
Fiab Spa
General Hospital · 304d
Cleared Nov 07, 2018
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
K180683 · PQX
Certa Dose, Inc.
General Hospital · 237d
Cleared Nov 07, 2018
Powder Free Vinyl Patient Examination Gloves
K180381 · LYZ
Shanxi Hongjin Plastic Technology...
General Hospital · 268d
Cleared Nov 06, 2018
Merit Syringe
K182279 · FMF
Merit Medical Systems, Inc.
General Hospital · 76d
Cleared Nov 06, 2018
Merit Syringe
K182216 · FMF
Merit Medical Systems, Inc.
General Hospital · 83d
Cleared Nov 06, 2018
SMARTRELEASE Endoscopic Soft Tissue Release System
K181819 · HRX
Microaire Surgical Instruments, LLC
General Hospital · 120d
Cleared Nov 02, 2018
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy...
K182096 · LZA
Owens & Minor Halyard, Inc.
General Hospital · 91d
Cleared Nov 02, 2018
Vygon Midline 3 Fr SL Catheter
K181208 · PND
Vygon USA
General Hospital · 179d
Cleared Nov 02, 2018
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K180786 · LZA
Hartalega Sdn Bhd
General Hospital · 221d
Cleared Oct 29, 2018
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
K181239 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 172d
Cleared Oct 25, 2018
Swaive Thermometer SWT1A
K170723 · FLL
E-Care Technology Co., Ltd.
General Hospital · 595d
Cleared Oct 23, 2018
BD Single Use, Hypodermic Syringe
K172670 · FMF
Becton, Dickinson and Company
General Hospital · 413d
Cleared Oct 22, 2018
TD-1035 Thermometer
K172733 · FLL
Taidoc Technology Corporation
General Hospital · 406d
Cleared Oct 18, 2018
BD FlowSmart Set/MiniMed Pro-Set
K181718 · FPA
Becton, Dickinson and Company
General Hospital · 111d
Cleared Oct 10, 2018
SBG Black Nitrile Powder Free Medical Examination Glove
K180468 · LZA
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Oct 10, 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
K180467 · LZA
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Oct 10, 2018
Temperature Probe
K173194 · FLL
Orantech, Inc.
General Hospital · 373d
Cleared Oct 06, 2018
Vinyl Patient Examination Gloves
K182117 · LYZ
Jiangxi Zhonghong Pulin Medical...
General Hospital · 61d
Cleared Oct 03, 2018
Vinyl Patient Examination Gloves
K182115 · LYZ
Pingan Medical Products Co., Ltd.
General Hospital · 58d
Cleared Oct 02, 2018
Infrared Ear Thermometer
K181081 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 161d
Cleared Oct 02, 2018
KLOCKNER SURGICAL BOX
K173642 · KCT
SOADCO, S.L.
General Hospital · 312d