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
2785–2808 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 15, 2017
ArchFlo CT Midline
K171483 · PND
Medcomp (Dba Medical Components, Inc.)
General Hospital · 207d
Cleared Dec 14, 2017
ISP Safety Huber Needle Infusion Set
K170881 · PTI
Infusion Safety Products, Inc.
General Hospital · 265d
Cleared Dec 13, 2017
Disposable Insulin Pen Needle
K170846 · FMI
Jiangsu Caina Technology Co., Ltd.
General Hospital · 267d
Cleared Dec 12, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K173137 · LZA
Hartalega Sdn Bhd
General Hospital · 74d
Cleared Dec 12, 2017
SporView Rapid Read Biological Indicator
K172432 · FRC
Crosstex/Spsmedical, A Division of...
General Hospital · 123d
Cleared Dec 12, 2017
DropSafe Safety Pen Needle
K170988 · FMI
Htl-Strefa S.A
General Hospital · 253d
Cleared Dec 11, 2017
Safety Blood Collection Device for Single Use
K170276 · FMI
Gemtier Medical (Shanghai), Inc.
General Hospital · 315d
Cleared Dec 08, 2017
RoyalGuard Surgical Gown, i600, Breathable
K172445 · FYA
Gri Medical & Electrical Technology...
General Hospital · 116d
Cleared Dec 06, 2017
C3 Wave System
K170934 · LJS
Medical Components, Inc. (dba MedComp)
General Hospital · 251d
Cleared Nov 30, 2017
Graft Delivery, DePuy Synthes
K173385 · FMF
Micromedics, Inc. (D/B/A Nordson...
General Hospital · 31d
Cleared Nov 30, 2017
Infrared thermometer
K171578 · FLL
Shenzhen Aeon Technology Co., Ltd.
General Hospital · 183d
Cleared Nov 28, 2017
Orange Non Sterile Powder Free Nitrile Examination Gloves
K172642 · LZC
Central Medicare Sdn Bhd
General Hospital · 88d
Cleared Nov 24, 2017
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
K172678 · LZA
Shen Wei (Usa), Inc.
General Hospital · 80d
Cleared Nov 24, 2017
SALUS - Hygiene Instrument Reprocessing Container
K172292 · KCT
Scican , Ltd.
General Hospital · 116d
Cleared Nov 22, 2017
Non Contact Infrared Forehead Thermometer
K170662 · FLL
Intrinity Global Limited
General Hospital · 264d
Cleared Nov 17, 2017
SterilContainer with PrimeLine Pro Lid
K172850 · KCT
Aesculap, Inc.
General Hospital · 58d
Cleared Nov 17, 2017
Micro-MEC 1.8% Glutaraldehyde Monitor Strip
K172472 · JOJ
STERIS Corporation
General Hospital · 94d
Cleared Nov 17, 2017
Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free...
K171743 · LZA
Smart Glove Corporation Sdn. Bhd.
General Hospital · 158d
Cleared Nov 15, 2017
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
K173016 · LYZ
Anhui Kindguard Medical Supplies...
General Hospital · 49d
Cleared Nov 15, 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile,...
K171873 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 145d
Cleared Nov 13, 2017
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with...
K172525 · LZC
Central Medicare Sdn Bhd
General Hospital · 84d
Cleared Nov 09, 2017
DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +...
K170900 · FMF
Intervene Group, Ltd.
General Hospital · 227d
Cleared Nov 08, 2017
MHC Standard and NRFit Tip Syringes
K171131 · FMF
Mazza Healthcare, LLC
General Hospital · 205d
Cleared Nov 07, 2017
Insulia Diabetes Management Companion
K172177 · NDC
Voluntis Sa.
General Hospital · 111d