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
104617–104640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1995
PACIFIC COMMUNICATIONS MODEL 1100
K942147 · DSI
Accucore, Inc.
Cardiovascular · 272d
Cleared Jan 30, 1995
VISUALINE II MORPHINE/OPIATES/HEROIN
K943248 · DJG
Sun Biomedical Laboratories, Inc.
Toxicology · 208d
Cleared Jan 30, 1995
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
K943493 · JJE
Hamilton Co.
Chemistry · 195d
Cleared Jan 30, 1995
MAMMOCORE BIOPSY TRAY
K943653 · FRG
Manan Medical Products, Inc.
General Hospital · 186d
Cleared Jan 30, 1995
INCARE HOT/ICE COLD THERAPY COOLER
K944971 · ILO
Hollister, Inc.
Physical Medicine · 111d
Cleared Jan 30, 1995
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
K945277 · DXJ
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Jan 30, 1995
ADVANTX LCA
K945375 · IZI
GE Medical Systems
Radiology · 89d
Cleared Jan 30, 1995
DFS-700
K945388 · LLZ
Shimadzu Corp.
Radiology · 88d
Cleared Jan 30, 1995
DLX
K945459 · IZI
General Electric Co.
Radiology · 84d
Cleared Jan 30, 1995
HIGH TEMPERATURE CAUTERY
K945492 · GEI
Aaron Medical Industries
General & Plastic Surgery · 90d
Cleared Jan 30, 1995
OPHTHALMIC CAUTERY
K945493 · HQP
Aaron Medical Industries
Ophthalmic · 90d
Cleared Jan 30, 1995
DSP OPTION
K945580 · IZJ
Philips Medical Systems (Cleveland),...
Radiology · 77d
Cleared Jan 30, 1995
GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES
K945676 · GZJ
Selectivemed Components, Inc.
Neurology · 73d
Cleared Jan 30, 1995
HIGH TEMPERATURE CAUTERY FINE ADJUSTABLE
K945757 · GEI
Aaron Medical Industries
General & Plastic Surgery · 90d
Cleared Jan 30, 1995
HIGH TEMPERATURE CAUTERY 5 LOOP
K945759 · GEI
Aaron Medical Industries
General & Plastic Surgery · 90d
Cleared Jan 30, 1995
HIGH TEMPERATURE CAUTERY
K945760 · GEI
Aaron Medical Industries
General & Plastic Surgery · 90d
Cleared Jan 30, 1995
HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP
K945764 · KNS
Aaron Medical Industries
Gastroenterology & Urology · 90d
Cleared Jan 30, 1995
HIGH TEMPERATURE CAUTERY
K945765 · GEI
Aaron Medical Industries
General & Plastic Surgery · 90d
Cleared Jan 30, 1995
OTICON
K946045 · ESD
Oticon, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 30, 1995
LX-ITC
K946071 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 119d
Cleared Jan 30, 1995
CIBA CORNING 8-- SERIES CO-OXIMETER
K946206 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 40d
Cleared Jan 30, 1995
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224 · JJS
Ciba Corning Diagnostics Corp.
Chemistry · 77d
Cleared Jan 30, 1995
ENDOXFLEX 5000
K946239 · GCJ
Michael A Clark
General & Plastic Surgery · 39d
Cleared Jan 30, 1995
MAICO IN-THE-EAR MODEL RD 201
K946253 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 38d