Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
2449–2472 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 26, 2019
Megadyne Foot Switch
K191328 · FYD
Megadyne Medical Products, Inc.
General Hospital · 71d
Cleared Jul 26, 2019
Infrared Ear/Forehead Thermometer
K190873 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 114d
Cleared Jul 26, 2019
STATCLAVE G4 Chamber Autoclave
K190062 · FLE
Scican , Ltd.
General Hospital · 192d
Cleared Jul 26, 2019
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested...
K183280 · LZA
Smart Glove Corporation Sdn. Bhd.
General Hospital · 245d
Cleared Jul 22, 2019
Powder-Free Vinyl Patient Examination Gloves, Yellow Color
K191092 · LYZ
Anhui Intco Medical Products Co., Ltd.
General Hospital · 89d
Cleared Jul 19, 2019
STERIZONE(R) VP4 Sterilizer
K190260 · PJJ
Tso3, Inc.
General Hospital · 161d
Cleared Jul 18, 2019
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit,...
K191060 · DXT
Acist Medical Systems, Inc.
General Hospital · 87d
Cleared Jul 18, 2019
Immucise
K190427 · FMF
Terumo Corporation
General Hospital · 146d
Cleared Jul 16, 2019
Microlife Digital Infrared Ear Thermometer
K183663 · FLL
Microlife Intellectual Property GmbH
General Hospital · 201d
Cleared Jul 12, 2019
AMSafe(R) Pre-Filled Normal Saline Flush Syringe
K183473 · NGT
Amsino International, Inc.
General Hospital · 210d
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