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
100585–100608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1995
ARGISTAR BIO 75PF
K954367 · EJT
Argen Precious Metals, Inc.
Dental · 22d
Cleared Oct 07, 1995
ARGEDENT BIO 87 PF
K954368 · EJT
Argen Precious Metals, Inc.
Dental · 22d
Cleared Oct 07, 1995
SUREFIRE S
K954371 · EJT
Argen Precious Metals, Inc.
Dental · 18d
Cleared Oct 07, 1995
AUROLITE 45
K954404 · EJT
Argen Precious Metals, Inc.
Dental · 17d
Cleared Oct 07, 1995
UNITRON MODEL SOUND F/X II
K954516 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 9d
Cleared Oct 07, 1995
MIRACLE - EAR MODEL PBP
K954528 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 8d
Cleared Oct 07, 1995
PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM
K954596 · FCG
Promedical , Ltd.
Gastroenterology & Urology · 4d
Cleared Oct 06, 1995
PROFILE 7000 C-SPINE COIL
K943440 · LNH
Us Asia Instruments, Inc.
Radiology · 445d
Cleared Oct 06, 1995
BRAUN DIACAN(R) FISTULA NEEDLES
K945850 · FIE
B. Braun of America, Inc.
Gastroenterology & Urology · 310d
Cleared Oct 06, 1995
ZYMED TELEMETRY SYSTEM
K951370 · DSI
Zymed Medical Instrumentation
Cardiovascular · 193d
Cleared Oct 06, 1995
AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)
K951684 · JOW
Digital Air Corp.
Cardiovascular · 178d
Cleared Oct 06, 1995
COULTER Z 1
K952308 · GKL
Coulter Corp.
Hematology · 142d
Cleared Oct 06, 1995
LEEP SYSTEM 1000
K952483 · HGI
CooperSurgical, Inc.
Obstetrics & Gynecology · 129d
Cleared Oct 06, 1995
AFFINITY ARTERIAL BLOOD FILTER
K952532 · DTM
Avecor Cardiovascular, Inc.
Cardiovascular · 127d
Cleared Oct 06, 1995
MDA SIMPLASTIN LS
K952608 · GJS
Organon Teknika Corp.
Hematology · 121d
Cleared Oct 06, 1995
SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940
K952661 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 116d
Cleared Oct 06, 1995
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
K952775 · MGQ
Deroyal Industries, Inc.
General & Plastic Surgery · 112d
Cleared Oct 06, 1995
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · DKZ
Abbott Laboratories
Toxicology · 95d
Cleared Oct 06, 1995
CLM LARYNGOSCOPE
K953179 · CCW
Penlon , Ltd.
Anesthesiology · 88d
Cleared Oct 06, 1995
22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN
K953219 · GXY
Chalgren Enterprises, Inc.
Neurology · 88d
Cleared Oct 06, 1995
32MM NICKEL PLATED DISC ELECTRODE
K953220 · GXY
Chalgren Enterprises, Inc.
Neurology · 88d
Cleared Oct 06, 1995
SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES
K953242 · KNF
Symbiosis Corp.
Obstetrics & Gynecology · 87d
Cleared Oct 06, 1995
TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM
K953284 · MHI
Trend Scientific, Inc.
Microbiology · 85d
Cleared Oct 06, 1995
DIASTAT VASCULAR ACCESS GRAFT
K953287 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 85d