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
2953–2976 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 05, 2017
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
K170152 · KGO
Hartalega Sdn Bhd
General Hospital · 108d
Cleared May 02, 2017
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
K160781 · KGO
Semperit Investments Asia Pte , Ltd.
General Hospital · 406d
Cleared Apr 28, 2017
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
K170070 · FRC
STERIS Corporation
General Hospital · 109d
Cleared Apr 28, 2017
Introcan Safety 3 Closed IV Catheter
K163358 · FOZ
B.Braun Melsungen AG
General Hospital · 149d
Cleared Apr 28, 2017
VERIFY ASSERT STEAM Process Challenge Device
K162945 · OWP
STERIS Corporation
General Hospital · 189d
Cleared Apr 28, 2017
Self Sealing Sterilization Pouches
K162258 · FRG
Tianchang Jiarui Packaging Material...
General Hospital · 260d
Cleared Apr 28, 2017
Scope-Assist Flushing Sink
K162120 · FEB
Custom Ultrasonics, Inc.
General Hospital · 270d
Cleared Apr 27, 2017
Instrument kits
K160730 · KCT
Anthogyr
General Hospital · 407d
Cleared Apr 26, 2017
Pro-Lock CT Safety Infusion Set
K162271 · PTI
Medcomp (Medical Components, Inc.)
General Hospital · 257d
Cleared Apr 24, 2017
PowerPICC Provena Catheters with SOLO Valve Technology
K162441 · LJS
C.R. Bard, Inc.
General Hospital · 236d
Cleared Apr 21, 2017
Braun No Touch + Forehead NTF3000 Thermometer
K163516 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 127d
Cleared Apr 21, 2017
Aero Chrome* Select Breathable Performance Surgical Gowns
K162930 · FYA
Halyard Health, Inc.
General Hospital · 184d
Cleared Apr 21, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED...
K162294 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 249d
Cleared Apr 21, 2017
Steri-Cassette and Steri-Cage Sterilization Packaging System
K162063 · KCT
Sybron Dental Specialties
General Hospital · 269d
Cleared Apr 20, 2017
QiF Blood and Fluid Warmer
K163708 · LGZ
Quality IN Flow , Ltd.
General Hospital · 112d
Cleared Apr 20, 2017
Sterile Single-use Infusion Set
K163160 · FPA
Jiangxi Hongda Medical Equipment...
General Hospital · 161d
Cleared Apr 20, 2017
Cardinal Health Sterilization Wrap
K161910 · FRG
Cardinal Health200, LLC
General Hospital · 282d
Cleared Apr 19, 2017
VisioFocus Mini, VisioFocus Smart
K160680 · FLL
Tecnimed S.R.L.
General Hospital · 405d
Cleared Apr 18, 2017
OmniPod Insulin Management System
K162296 · LZG
Insulet Corporation
General Hospital · 245d
Cleared Apr 17, 2017
PowerFlow Apheresis I.V. Port
K163001 · PTD
C.R. Bard, Inc.
General Hospital · 171d
Cleared Apr 12, 2017
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin...
K170386 · FMF
Becton, Dickinson Company
General Hospital · 63d
Cleared Apr 07, 2017
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
K163144 · FRC
Gke-GmbH
General Hospital · 149d
Cleared Apr 07, 2017
VOCSN Unified Respiratory System
K162877 · CBK
Ventec Life Systems, Inc.
General Hospital · 175d
Cleared Apr 06, 2017
Dual Mode Infrared Thermometer
K163256 · FLL
Intelliworks, LLC
General Hospital · 136d