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
121849–121872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1991
EMISSION TOMOGRAPHY CAROUSEL
K896151 · KPS
Atf Consolidated
Radiology · 539d
Cleared Apr 16, 1991
DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP
K903298 · ELC
Micro Motors, Inc.
Dental · 266d
Cleared Apr 16, 1991
SHIMADZU IMAGE PROCESSOR DFS-500
K905132 · LLZ
Shimadzu Medical Systems
Radiology · 152d
Cleared Apr 16, 1991
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL
K905457 · DIF
Consolidated Technologies, Inc.
Chemistry · 132d
Cleared Apr 16, 1991
MASTER FLOW I.V. PUMPETTE
K905497 · LDR
The Master Medical Corp.
General Hospital · 130d
Cleared Apr 16, 1991
STAT 2 IV PUMPETTE
K905498 · LDR
The Master Medical Corp.
General Hospital · 130d
Cleared Apr 16, 1991
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
K905807 · GJS
Helena Laboratories
Hematology · 110d
Cleared Apr 16, 1991
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · LHI
Abbott Laboratories
General Hospital · 96d
Cleared Apr 16, 1991
IMMULITE(TM) TOTAL T4
K910261 · KLI
Cirrus Diagnostics, Inc.
Chemistry · 84d
Cleared Apr 16, 1991
Y ADAPTOR
K910321 · KOC
Akcess Medical Products, Inc.
Gastroenterology & Urology · 82d
Cleared Apr 16, 1991
VIDEO ANNOTATOR MODEL PK2310
K910384 · JAA
Perkins Mfg. Co.
Radiology · 77d
Cleared Apr 16, 1991
RESPI-PAK RT-PAK
K910452 · BZG
Cns, Inc.
Anesthesiology · 74d
Cleared Apr 16, 1991
SAFETYSNAP SAFETY SYRINGE
K910520 · FMF
U.S. Medical Instruments, Inc.
General Hospital · 69d
Cleared Apr 16, 1991
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
K910716 · FCX
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 55d
Cleared Apr 16, 1991
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · KDI
Abbott Laboratories
Gastroenterology & Urology · 34d
Cleared Apr 16, 1991
CHLORIDE REAGENT
K911297 · CHJ
Intersect Systems, Inc.
Chemistry · 22d
Cleared Apr 16, 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
K911339 · IZO
Shimadzu Medical Systems
Radiology · 21d
Cleared Apr 16, 1991
OPUS FSH
K911409 · CGJ
Pb Diagnostic Systems, Inc.
Toxicology · 15d
Cleared Apr 16, 1991
LATEX EXAMINATION GLOVES (HYPOALLERGENIC)
K911447 · LYY
Aladan Corp.
General Hospital · 39d
Cleared Apr 16, 1991
MULTIPLE BIOPSY DEVICE-MBX
K911448 · FCK
Triton Technology, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 16, 1991
REP SPE PLUS (ACID BLUE) SYSTEM
K911468 · CEF
Helena Laboratories
Chemistry · 13d
Cleared Apr 15, 1991
PERIOGARD(R) PERIOPEN
K901955 · EFS
Colgate-Palmolive Co.
Dental · 349d
Cleared Apr 15, 1991
LUXAR MODEL LX-20 CO2 LASER
K904068 · GEX
Luxar Corp.
General & Plastic Surgery · 227d
Cleared Apr 15, 1991
ZIRCONIA CERAMIC MODULAR HEADS
K905687 · LZO
Biomet, Inc.
Orthopedic · 117d