FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83473–83496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1999
POWDER FREE LATEX STERILE SURGICAL GLOVES
K993562 · KGO
Tg Medical Sdn. Bhd.
General Hospital · 69d
Cleared Dec 29, 1999
RESOLVE QUICKANCHOR
K993575 · DZL
Mitek Products
Dental · 69d
Cleared Dec 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES,...
K993621 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 64d
Cleared Dec 29, 1999
INVIGRA
K993693 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 57d
Cleared Dec 29, 1999
MODUS SAGITTAL SPLIT PLATE
K993862 · JEY
The Straumann Co.
Dental · 44d
Cleared Dec 29, 1999
DISENTRONIC PENFINE INJECTION PEN NEEDLE
K994197 · FMI
Disetronic Medical Systems
General Hospital · 16d
Cleared Dec 28, 1999
CADENCE DOPPLER ULTRASOUND SYSTEM
K991441 · KNG
Medasonics, Inc.
Radiology · 246d
Cleared Dec 28, 1999
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08,...
K991541 · DWF
A-Med Systems, Inc.
Cardiovascular · 239d
Cleared Dec 28, 1999
PASCAL MEDICAL AB MENIETT 20
K991562 · ETY
Pascal Medical AB
Ear, Nose, Throat · 238d
Cleared Dec 28, 1999
BLADEWORKS DISPOSABLE ALK TUBING
K993591 · KYG
Blade Works, Inc.
Ophthalmic · 67d
Cleared Dec 28, 1999
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
K993643 · MWJ
Nexan Telemed , Ltd.
Cardiovascular · 61d
Cleared Dec 28, 1999
URETERAL ACCESS SHEATH SET - NEW MODELS
K993650 · FED
Applied Medical Resources
Gastroenterology & Urology · 60d
Cleared Dec 28, 1999
CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
K993761 · LLZ
Medis Medical Imaging Systems BV
Radiology · 50d
Cleared Dec 27, 1999
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
K983860 · JMK
Polymer Technology Systems, Inc.
Chemistry · 420d
Cleared Dec 27, 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · KWQ
Spineology, Inc.
Orthopedic · 280d
Cleared Dec 27, 1999
DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)
K992482 · GEX
Radiancy, Ltd.
General & Plastic Surgery · 154d
Cleared Dec 27, 1999
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
K992949 · LDJ
Drug Detection Devices, Ltd.
Toxicology · 117d
Cleared Dec 27, 1999
ELITE CUSTOM
K993142 · LKY
Soma Blue, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 27, 1999
VITALITY SYSTEM
K993143 · LKY
Soma Blue, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 27, 1999
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF...
K993485 · DIO
Sun Biomedical Laboratories, Inc.
Chemistry · 74d
Cleared Dec 27, 1999
CARESIDE DIRECT BILIRUBIN
K993771 · CIG
Careside, Inc.
Chemistry · 49d
Cleared Dec 27, 1999
SODEM PERFORATOR DRIVE
K993851 · HBB
Sodemsystems
Neurology · 45d
Cleared Dec 27, 1999
K-ASSAY MULTI-ANALYTE CALIBRATOR
K993853 · JIX
Kamiya Biomedical Co.
Chemistry · 45d
Cleared Dec 27, 1999
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE,...
K993936 · KNW
Imagyn Surgical
Gastroenterology & Urology · 38d