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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123553–123576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1990
90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET
K903869 · KDJ
Fresenius/Delmed, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 20, 1990
OSTEONICS SR GLENOID COMPONENTS
K903886 · KWS
Osteonics Reconstructive Products Div.
Orthopedic · 90d
Cleared Nov 20, 1990
EXEL A-V FISTULA SET
K903945 · FIE
Exel Intl.
Gastroenterology & Urology · 85d
Cleared Nov 20, 1990
SEP 90
K904103 · IZP
Elema-Schonander, Inc.
Radiology · 75d
Cleared Nov 20, 1990
PROSTHETIC CEMENT REMOVER
K904180 · LZV
Origin Medsystems, Inc.
Orthopedic · 70d
Cleared Nov 20, 1990
ADVANCED C- SPINE COIL
K904327 · LNH
Toshiba America Mri, Inc.
Radiology · 61d
Cleared Nov 20, 1990
SATC-1114, SHOULDER ABUTMENT TRANSFER COPING
K904460 · DZE
Minimatic Implant Technology
Dental · 50d
Cleared Nov 20, 1990
INSTRUMENTARIUM MEGA4, MODIFICATION
K904528 · LNH
Instrumentarium Imaging, Inc.
Radiology · 50d
Cleared Nov 20, 1990
LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS
K904541 · LDJ
Abbott Laboratories
Toxicology · 47d
Cleared Nov 20, 1990
CIBA CORNING ACS FSH IMMUNOASSAY
K904649 · CGJ
Ciba Corning Diagnostics Corp.
Chemistry · 40d
Cleared Nov 20, 1990
AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV
K904658 · KNW
Leigh Med Tech, Inc.
Gastroenterology & Urology · 36d
Cleared Nov 20, 1990
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
K904660 · JFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 36d
Cleared Nov 20, 1990
S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
K904746 · JDK
Joint Medical Products Corp.
Orthopedic · 33d
Cleared Nov 20, 1990
P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
K904761 · CIE
Instrumentation Laboratory CO
Chemistry · 32d
Cleared Nov 20, 1990
EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
K904764 · DKB
Syva Co.
Toxicology · 29d
Cleared Nov 20, 1990
CEDIA (R) VITAMIN B12/FOLATE ASSAY
K904776 · CDD
Microgenics Corp.
Chemistry · 29d
Cleared Nov 20, 1990
ORION PLUS/MODIFICATION
K904840 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 27d
Cleared Nov 20, 1990
MODEL 400 ULTRA COMPACT VIDEO IMAGER
K904897 · LMC
International Imaging Electronics
Radiology · 22d
Cleared Nov 20, 1990
SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN
K905094 · BYX
Medical Fittings, Inc.
Anesthesiology · 7d
Cleared Nov 19, 1990
WILSON-COOK PULL THROUGH PEG KIT
K901163 · FPD
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 251d
Cleared Nov 19, 1990
INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS
K902428 · LLZ
GE Medical Systems
Radiology · 172d
Cleared Nov 19, 1990
EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
K902764 · BYT
J. H. Emerson Co.
Anesthesiology · 147d
Cleared Nov 19, 1990
SHAVE PREP TRAY
K902813
Orion Life Systems, Inc.
General Hospital · 145d
Cleared Nov 19, 1990
P.R.G. GUIDEWIRE PLACEMENT SYSTEM
K903036 · KGC
Applied Medical Technologies
Gastroenterology & Urology · 131d