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
2425–2448 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 09, 2019
ENDOSCOPE REPROCESSOR OER-Elite
K190969 · FEB
Olympus Medical Systems Corp.
General Hospital · 88d
Cleared Jul 09, 2019
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch...
K181957 · FRG
Tianchang Jiarui Packaging Material...
General Hospital · 351d
Cleared Jul 08, 2019
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K190485 · JKA
Kawasumi Laboratories, Inc.
General Hospital · 131d
Cleared Jul 08, 2019
Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
K181456 · FLE
Tuttnauer , Ltd.
General Hospital · 399d
Cleared Jul 08, 2019
Bard Power-Injectable Implantable Ports (PowerPorts®)
K181446 · LJT
C.R. Bard, Inc.
General Hospital · 402d
Cleared Jul 05, 2019
Aesculap® SterilContainer(TM) S2 System
K182414 · KCT
Aesculap, Inc.
General Hospital · 304d
Cleared Jul 04, 2019
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3...
K190950 · FYA
Medline Industries, Inc.
General Hospital · 84d
Cleared Jul 04, 2019
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with...
K183149 · LZC
Central Medicare Sdn Bhd
General Hospital · 233d
Cleared Jun 28, 2019
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical...
K183389 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 204d
Cleared Jun 27, 2019
FlexGard Cut-Resistant Glove Liners
K190782 · KGO
Ldi Corporation
General Hospital · 92d
Cleared Jun 27, 2019
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs...
K190080 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 162d
Cleared Jun 26, 2019
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with...
K182851 · LZA
O&M Halyard, Inc.
General Hospital · 259d
Cleared Jun 20, 2019
Powder-Free Clear Vinyl Patient Examination Gloves
K190095 · LYZ
Anhui Intco Medical Products Co., Ltd.
General Hospital · 149d
Cleared Jun 20, 2019
Powder Free Blue Nitrile Examination Gloves Tested for use with 32...
K183354 · LZA
Gx Corporation Sdn Bhd
General Hospital · 199d
Cleared Jun 18, 2019
Med-link Temperature Probes
K182667 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 266d
Cleared Jun 14, 2019
Medline Digital Rectal Thermometer Sheath
K183431 · FLL
Medline Industries, Inc.
General Hospital · 185d
Cleared Jun 13, 2019
Sonopet iQ Sterilization Tray
K190667 · KCT
Paragon Medical
General Hospital · 90d
Cleared Jun 11, 2019
JAMBRO Single Core A Sterilization wrap
K182656 · FRG
Jiangsu Zhande Medical Supplies Co.,...
General Hospital · 259d
Cleared Jun 07, 2019
Ivenix Infusion System (IIS)
K183311 · FRN
Ivenix, Inc.
General Hospital · 190d
Cleared May 31, 2019
Tiger Sharps Containers
K190240 · MMK
International Marketing Specialists,...
General Hospital · 114d
Cleared May 30, 2019
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with...
K182308 · LZA
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital · 279d
Cleared May 28, 2019
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K190606 · LZA
Kossan International Sdn Bhd
General Hospital · 81d
Cleared May 28, 2019
Clearlink System Solution Set
K180739 · FPA
Baxter Healthcare Corporation
General Hospital · 432d
Cleared May 27, 2019
Surgical Face Mask
K182515 · FXX
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 257d