FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76489–76512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2002
DEPILASE TWIN LASE LASER SYSTEM
K020412 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 15d
Cleared Feb 22, 2002
PORTABLE X-RAY UNITS
K020436 · IZL
Sedecal., Sa.
Radiology · 14d
Cleared Feb 21, 2002
SPHYGMOCOR PX MODEL SCOR-PX
K012487 · DXN
Atcor Medical Pty, Ltd.
Cardiovascular · 203d
Cleared Feb 21, 2002
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
K013241 · BWC
Cook, Inc.
Anesthesiology · 146d
Cleared Feb 21, 2002
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
K013252 · BWC
Cook, Inc.
Anesthesiology · 146d
Cleared Feb 21, 2002
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
K013862 · DQA
Bci, Inc.
Anesthesiology · 92d
Cleared Feb 21, 2002
PROVOX HME CASSETTE, MODEL 7240
K014102 · JOH
Atos Medical AB
Anesthesiology · 70d
Cleared Feb 21, 2002
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
K020018 · MSX
Cardiopulmonary Corp.
Cardiovascular · 49d
Cleared Feb 21, 2002
MODIFICATION TO DATACAPTOR
K020197 · MWI
Capsule Technologie
Cardiovascular · 30d
Cleared Feb 21, 2002
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123,...
K020204 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 21, 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K020494 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 8d
Cleared Feb 20, 2002
ENRAF-NONIUS ENDOMED 182 SYSTEM
K003744 · GZJ
Henley Healthcare, Inc.
Neurology · 443d
Cleared Feb 20, 2002
SI ASCOPE
K011273 · PSN
Astron Clinica Limited
General & Plastic Surgery · 300d
Cleared Feb 20, 2002
MODIFICATION TO WARTNER WART REMOVAL SYSTEM
K011708 · GEH
Wartner Medical Products
General & Plastic Surgery · 261d
Cleared Feb 20, 2002
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
K013259 · HKX
Leica Microsystems, Inc. O.I.D.
Ophthalmic · 142d
Cleared Feb 20, 2002
DFINER UROLOGICAL CATHETER
K013360 · FGI
Neoseed Technology,Llc
Gastroenterology & Urology · 133d
Cleared Feb 20, 2002
BABYCOM
K013547 · KNG
Pmg Medica , Ltd.
Radiology · 119d
Cleared Feb 20, 2002
NEUROSENSOR
K013930 · GWM
Novus Monitoring, Ltd.
Neurology · 84d
Cleared Feb 20, 2002
UNIFIL BOND
K013997 · KLE
GC America, Inc.
Dental · 78d
Cleared Feb 20, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K014202 · LPN
Allergan, Inc.
Ophthalmic · 61d
Cleared Feb 20, 2002
SYNTHES CRANIAL PLATES
K020087 · JEY
Synthes (Usa)
Dental · 41d
Cleared Feb 20, 2002
VASOVIEW 5 HARVESTING CANNULA
K020143 · HET
Guidant Corporation, Cardiac Surgery
Obstetrics & Gynecology · 35d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 146d
Cleared Feb 19, 2002
CRYSTAL MONITOR MODEL 16
K013863 · OMC
Cleveland Medical Devices, Inc.
Neurology · 90d