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
3385–3408 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 15, 2015
MedSource ClearSafe Safety IV Catheter
K150611 · FOZ
Medsource International
General Hospital · 127d
Cleared Jul 15, 2015
The VersaJet II Hydrosurgery System
K143115 · FQH
Smith & Nephew, Inc.
General Hospital · 258d
Cleared Jul 14, 2015
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with...
K142190 · KGO
Pt. Medisafe Technologies
General Hospital · 340d
Cleared Jul 09, 2015
Penguin In-Line Warmer
K150484 · LGZ
Creche Innovations
General Hospital · 135d
Cleared Jul 09, 2015
Powder Free Vinyl Patient Examination Gloves, Yellow Color
K143340 · LYZ
Zibo Ling Yun Medical Products Co, Ltd.
General Hospital · 230d
Cleared Jul 08, 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
K151513 · FOZ
Arrow Internation, Inc. (Subsidiary...
General Hospital · 34d
Cleared Jul 08, 2015
SterilContainer S System
K142970 · KCT
Aesculap, Inc.
General Hospital · 267d
Cleared Jul 07, 2015
Graft Delivery Device with Integrated Stylet
K151543 · FMF
Micromedics, Inc. (D/B/A Nordson...
General Hospital · 29d
Cleared Jul 07, 2015
Disposable Safety Self-destructive Syringes, 5 ML
K143070 · MEG
Jiangsu Yile Medical Article Co., Ltd.
General Hospital · 253d
Cleared Jul 02, 2015
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization
K150477 · JOJ
3M Company
General Hospital · 128d
Cleared Jun 25, 2015
K-Pack II Needle - 29G x 5/16 Thin Wall
K151398 · FMI
Terumo Europe N.V.
General Hospital · 30d
Cleared Jun 25, 2015
Droplet Pen Needles
K143437 · FMI
Htl-Strefa S.A
General Hospital · 206d
Cleared Jun 24, 2015
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
K133080 · KKX
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 632d
Cleared Jun 24, 2015
Plus Surgical Gowns (EO Sterilized), PMGB-XXX
K133075 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 632d
Cleared Jun 22, 2015
Instru-Safe Instrument Protection System
K150540 · KCT
Summit Medical, Inc.
General Hospital · 111d
Cleared Jun 22, 2015
SURGICAL FACE MASK (Ear Loops and Tie-on)
K133070 · FXX
Bh Medical Products Co., Ltd.
General Hospital · 630d
Cleared Jun 18, 2015
Safety Disposable Insulin Syringe
K150758 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 87d
Cleared Jun 18, 2015
POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue),...
K150340 · LZA
Hebei Hongsen Plastics Technology Co,...
General Hospital · 127d
Cleared Jun 18, 2015
Fusion Black Powder-Free Nitrile Exam Glove
K150113 · LZA
Halyard Health
General Hospital · 149d
Cleared Jun 18, 2015
I.V. Catheter
K142797 · FOZ
Jiangxi Sanxin Medtec Co., Ltd.
General Hospital · 262d
Cleared Jun 18, 2015
Infusomat Space Volumetric Infusion Pump
K142596 · FRN
B.Braun Medical, Inc.
General Hospital · 276d
Cleared Jun 17, 2015
BELIMED STEAM STERILIZER MST-H
K141879 · FLE
Sauter AG
General Hospital · 341d
Cleared Jun 12, 2015
Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model...
K150414 · LZA
Industrial Clothings (Pvt), Ltd.
General Hospital · 114d
Cleared Jun 12, 2015
Luma Wrap
K142416 · PDH
Salter Labs
General Hospital · 288d