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
2401–2424 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 05, 2019
bili-hut
K190899 · LBI
Little Sparrows Technologies, Inc.
General Hospital · 150d
Cleared Sep 03, 2019
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc...
K182765 · FMF
Top Corporation
General Hospital · 340d
Cleared Aug 29, 2019
EvaQMax Smoke Evacuation System
K192035 · FYD
Bio Protech, Inc.
General Hospital · 30d
Cleared Aug 29, 2019
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic...
K191475 · KCT
Nobel Biocare AB
General Hospital · 86d
Cleared Aug 29, 2019
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination...
K182382 · LZC
Gmp Medicare Sdn Bhd (F25)
General Hospital · 363d
Cleared Aug 21, 2019
RAS 12 Rack, RAS 12 Long Rack
K190081 · NVE
STERIS Corporation
General Hospital · 217d
Cleared Aug 19, 2019
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical...
K183356 · FRG
Weihai Xingtai Packaging Products...
General Hospital · 258d
Cleared Aug 16, 2019
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K183536 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 240d
Cleared Aug 15, 2019
HCT Empty EVA Container Pack
K190328 · KPE
Health Care Technologies
General Hospital · 183d
Cleared Aug 02, 2019
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization...
K191741 · JOJ
Intertape Polymer, Inc.
General Hospital · 32d
Cleared Aug 02, 2019
PowerFlow Implantable Apheresis IV Port
K191143 · PTD
C.R. Bard, Inc.
General Hospital · 94d
Cleared Jul 30, 2019
Powder Free Blue Nitrile Examination Gloves - Tested for Use with...
K182089 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 362d
Cleared Jul 30, 2019
Blood Collection Accessory (BUCA)
K181754 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 393d
Cleared Jul 30, 2019
Blood Transfer Accessory (BTA)
K181743 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 393d
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