FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
110065–110088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1994
HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM
K925111 · GWN
Eye Dynamics, Inc.
Neurology · 530d
Cleared Mar 23, 1994
DIAGNOSTIC INTRAVASCULAR CATHETER
K925813 · DQO
Target Therapeutics
Cardiovascular · 491d
Cleared Mar 23, 1994
PULSATOR 5000
K930102 · GZJ
Toys House Industrial Corp.
Neurology · 439d
Cleared Mar 23, 1994
EMS
K931401 · IPF
Saratoga Intl., Inc.
Physical Medicine · 369d
Cleared Mar 23, 1994
CARAPACE LABOR AND DELIVERY SETS
K931722 · MLS
Carapace, Inc.
Obstetrics & Gynecology · 350d
Cleared Mar 23, 1994
HM-0660
K932782 · HEX
Hill-Med, Inc.
Obstetrics & Gynecology · 287d
Cleared Mar 23, 1994
HM-0690 COLPOSCOPE
K932896 · HEX
Hill-Med, Inc.
Obstetrics & Gynecology · 282d
Cleared Mar 23, 1994
ORTHOTECH DURA-GOLD BARCKETS
K933080 · EJF
Orthotech
Dental · 273d
Cleared Mar 23, 1994
CHECK VALVE (FITTING)
K933084 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 273d
Cleared Mar 23, 1994
EXTERNAL VEIN STRIPPER
K933498 · DWX
Applied Medical Resources
Cardiovascular · 247d
Cleared Mar 23, 1994
MS 2500
K933653 · IPF
Lsi Intl., Inc.
Physical Medicine · 238d
Cleared Mar 23, 1994
STB GUEDEL AIRWAY
K933760 · CAE
Save-T-Breath Distributors C.C.
Anesthesiology · 232d
Cleared Mar 23, 1994
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE
K933770 · LRC
Mahe-Medizintechnik
Ear, Nose, Throat · 237d
Cleared Mar 23, 1994
ARTHREX TOURNIQUET FOR LEG HOLDER
K933994 · KCY
Arthrex, Inc.
General & Plastic Surgery · 218d
Cleared Mar 23, 1994
ACUFEX ADJUSTABLE-LENGTH CANNULA
K934181 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 209d
Cleared Mar 23, 1994
SONICATOR 716
K934846 · IMG
Mettler Electronics Corp.
Physical Medicine · 166d
Cleared Mar 23, 1994
KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC
K934937 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 162d
Cleared Mar 23, 1994
FAMILY FIRST AID KIT
K935131 · LYY
Medical Technologies International, Inc.
General Hospital · 146d
Cleared Mar 23, 1994
CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES
K935356 · FWW
Amsco American Sterilizer Co.
General & Plastic Surgery · 139d
Cleared Mar 23, 1994
LASERSONICS TISSUE MORCELLATOR SET
K935604 · GCJ
Heraeus Surgical, Inc.
General & Plastic Surgery · 124d
Cleared Mar 23, 1994
POWDER-FREE LATEX EXAMINATION GLOVES
K935812 · LYY
Shen Wei (Usa), Inc.
General Hospital · 111d
Cleared Mar 23, 1994
PERCUTANEOUS TRACHEOSTOMY KIT
K936133 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 90d
Cleared Mar 23, 1994
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
K936183 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 86d
Cleared Mar 23, 1994
GORE SMOOTHER CRUCIAL TOOL
K936206 · HRX
W.L. Gore & Associates, Inc.
Orthopedic · 84d