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
2281–2304 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 21, 2020
Unity Subcutaneous Infusion System for Remodulin
K191313 · QJY
DEKA Research & Development
General Hospital · 282d
Cleared Feb 20, 2020
HydroPICC (PICC-142)
K193015 · LJS
Access Vascular, Inc.
General Hospital · 114d
Cleared Feb 20, 2020
Flowart
K190806 · FPA
Asset Medikal Tasarim As.
General Hospital · 328d
Cleared Feb 18, 2020
Safety Insulin Pen Needle
K192677 · FMI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 145d
Cleared Feb 13, 2020
Praxiject 0.9% NaCl
K192414 · NGT
Medxl, Inc.
General Hospital · 162d
Cleared Feb 13, 2020
Microlife Non-Contact Infrared Forehead Thermometer
K191829 · FLL
Microlife Intellectual Property GmbH
General Hospital · 219d
Cleared Feb 13, 2020
EleGARD Patient Positioning System
K191689 · FOA
Minnesota Resuscitation Solutions,...
General Hospital · 233d
Cleared Feb 10, 2020
InPen System
K192841 · NDC
Companion Medical, Inc.
General Hospital · 130d
Cleared Feb 07, 2020
3M Attest Super Rapid 5 Steam-Plus Challenge Pack
K193154 · FRC
3M Company
General Hospital · 85d
Cleared Feb 04, 2020
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button...
K191832 · JKA
Kurin, Inc.
General Hospital · 210d
Cleared Feb 03, 2020
Bella-mu
K190962 · FMI
U-Needle B.V.
General Hospital · 297d
Cleared Jan 31, 2020
Tamper Evident Cap
K193192 · FMF
International Medical Industries, Inc.
General Hospital · 73d
Cleared Jan 24, 2020
Gemini Titan Sterilization Wrap
K192641 · FRG
Medline Industries, Inc.
General Hospital · 122d
Cleared Jan 24, 2020
BD Cathena (TM) Safety IV Catheter
K192493 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 135d
Cleared Jan 24, 2020
Blue Nitrile Examination Gloves Powder Free
K192333 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 150d
Cleared Jan 23, 2020
STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
K192025 · FRC
Advanced Sterilization Products (Asp)
General Hospital · 178d
Cleared Jan 21, 2020
PIVO(TM)
K193569 · JKA
Velano Vascular
General Hospital · 29d
Cleared Jan 21, 2020
Medline Glide-On 3G Vinyl Examination Gloves
K192985 · LYZ
Medline Industries, Inc.
General Hospital · 88d
Cleared Jan 21, 2020
Hydro-Temp Neonatal Skin Temperature Probe Cover
K191425 · FMT
Deroyal Industries, Inc.
General Hospital · 237d
Cleared Jan 17, 2020
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
K192635 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 116d
Cleared Jan 17, 2020
AMD Ritmed AssureWear VersaGown
K190306 · FYC
Amd Medicom, Inc.
General Hospital · 339d
Cleared Jan 10, 2020
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with...
K192315 · LZA
Medline Industries, Inc.
General Hospital · 137d
Cleared Jan 07, 2020
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
K190942 · LZA
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 272d
Cleared Jan 06, 2020
TK Sterile Piston Syringe without Needle
K191642 · FMF
Anhui Tiankang Medical Technology...
General Hospital · 201d