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
2857–2880 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 14, 2017
MediClear PreOp
K163556 · KKX
Covalontechnologies, Inc.
General Hospital · 269d
Cleared Sep 12, 2017
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
K171144 · FMI
Medbio, LLC
General Hospital · 146d
Cleared Sep 11, 2017
Clear Vinyl Powder-free Patient Examination Gloves
K171317 · LYZ
Shandong Zhi Hong Medical Products,...
General Hospital · 130d
Cleared Sep 08, 2017
Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack...
K171805 · FMF
Conceptomed AS
General Hospital · 81d
Cleared Sep 08, 2017
Powder Free Nitrile Examination Glove
K171667 · LZA
Professional Latex Sdn Bhd
General Hospital · 95d
Cleared Sep 01, 2017
Carefusion NeutraClear Needle-free connector (EL-NC1000)
K171117 · FPA
Cair Lgl
General Hospital · 140d
Cleared Aug 31, 2017
Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter...
K163337 · FLE
Midmark Corporation
General Hospital · 276d
Cleared Aug 31, 2017
Integrated Catch-up Freedom Syringe Driver Infusion System
K162613 · FRN
Repro-Med Systems, Inc. Dba Rms...
General Hospital · 346d
Cleared Aug 29, 2017
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable...
K162165 · MEA
Summit Medical Products, Inc.
General Hospital · 391d
Cleared Aug 25, 2017
Standard Supreme Sterilization Wrapper
K172207 · FRG
Standard Textile Co., Inc.
General Hospital · 35d
Cleared Aug 25, 2017
Sapphire Sets
K171346 · MRZ
Icu Medical
General Hospital · 109d
Cleared Aug 25, 2017
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with...
K171104 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 134d
Cleared Aug 25, 2017
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and...
K170136 · LZA
Shandong Feiyang Professional Gloves...
General Hospital · 220d
Cleared Aug 24, 2017
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
K170982 · MEA
Smiths Medical Ads, Inc.
General Hospital · 143d
Cleared Aug 22, 2017
VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
K171587 · FRC
STERIS Corporation
General Hospital · 83d
Cleared Aug 22, 2017
VERIFY Assert VH2O2 Self-Contained Biological Indicator
K171504 · FRC
STERIS Corporation
General Hospital · 91d
Cleared Aug 21, 2017
Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with...
K171276 · KGO
Tg Medical Sdn. Bhd.
General Hospital · 112d
Cleared Aug 18, 2017
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With...
K171898 · KGO
Better Care Plastic Technology Co., Ltd.
General Hospital · 53d
Cleared Aug 17, 2017
BD Intima II PLUS Closed IV Catheter System
K172204 · FOZ
Becton, Dickinson and Company
General Hospital · 27d
Cleared Aug 17, 2017
Allerhope Allergy Skin Tester
K162917 · SCL
Procare Industrial Co., Limited
General Hospital · 303d
Cleared Aug 15, 2017
Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face...
K171162 · FXX
Prestige Ameritech
General Hospital · 117d
Cleared Aug 15, 2017
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
K171118 · FPA
Cair Lgl
General Hospital · 123d
Cleared Aug 14, 2017
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K170321 · JOJ
3M Company
General Hospital · 194d
Cleared Aug 10, 2017
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models...
K171116 · MSH
3M Healthcare
General Hospital · 118d