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
97225–97248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1996
SONY DKR-700 DIGITAL STILL RECORDER
K961680 · LMB
Sony Medical Systems
Radiology · 63d
Cleared Jul 03, 1996
IN-THE-EAR
K961827 · ESD
Qualitone
Ear, Nose, Throat · 51d
Cleared Jul 03, 1996
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
K961857 · DQD
Graham-Field, Inc.
Cardiovascular · 50d
Cleared Jul 03, 1996
RIONET HEARING AID HB53-K
K961907 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 03, 1996
LUNAR REPORT GENERATOR
K961944 · KGI
Lunar Corp.
Radiology · 44d
Cleared Jul 03, 1996
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
K961993 · MLS
Devon Industries, Inc.
Obstetrics & Gynecology · 43d
Cleared Jul 03, 1996
SELF CURE BONDING AGENT
K962277 · KLE
Dent Zar, Inc.
Dental · 20d
Cleared Jul 03, 1996
DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
K962290 · FOK
Debusk Technology Corp.
General Hospital · 19d
Cleared Jul 03, 1996
NON-GENERIC
K962310 · HQY
Classic Elegance Intl., Inc.
Ophthalmic · 16d
Cleared Jul 03, 1996
RADIOGRAPHIC FILM CASSETTES
K962336 · IXA
Unidex Group, Inc.
Radiology · 16d
Cleared Jul 03, 1996
RADIOGRAPHIC GRID
K962338 · IXJ
Unidex Group, Inc.
Radiology · 16d
Cleared Jul 03, 1996
NIKE V8 AND NIKE V12
K962412 · HQY
Nike, Inc.
Ophthalmic · 12d
Cleared Jul 02, 1996
CHEMMATE(TM) CD43
K950148 · DEH
Biotek Solutions, Inc.
Immunology · 532d
Cleared Jul 02, 1996
VAX-D THERAPEUTIC TABLE
K951622 · ITH
Vat-Tech, Inc.
Physical Medicine · 488d
Cleared Jul 02, 1996
RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM
K952429 · BZD
Rescare , Ltd.
Anesthesiology · 405d
Cleared Jul 02, 1996
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER
K955642 · DPS
Nellcor Puritan Bennett, Inc.
Cardiovascular · 203d
Cleared Jul 02, 1996
INTROSTAT LEAD INTRODUCER
K960200 · DYB
Msi, Inc.
Cardiovascular · 181d
Cleared Jul 02, 1996
A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR
K960319 · DXN
A&D Engineering, Inc.
Cardiovascular · 161d
Cleared Jul 02, 1996
DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
K960329 · MKJ
Contour Medical Technology, Inc.
Cardiovascular · 160d
Cleared Jul 02, 1996
CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE
K960667 · EBF
Wallace A. Erickson & Co.
Dental · 133d
Cleared Jul 02, 1996
PERCUGLIDE
K960917 · DRE
Scientific Device Manufacturer, LLC
Cardiovascular · 118d
Cleared Jul 02, 1996
NON-CORING NEEDLE
K961088 · FMI
Arrow Intl., Inc.
General Hospital · 105d
Cleared Jul 02, 1996
MEDCARE TRACHEOSTOMY CARE TRAY
K961167 · LRQ
Medcare Medical Group, Inc.
General & Plastic Surgery · 99d
Cleared Jul 02, 1996
GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE...
K961324 · MIA
Global Medical Prods, Inc.
Anesthesiology · 85d