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
70249–70272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2003
HL888 AF
K032913 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Oct 01, 2003
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061,...
K022505 · EGS
NOUVAG AG
Dental · 429d
Cleared Oct 01, 2003
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
K024023 · NFB
Essex Medical Systems Plus
Anesthesiology · 300d
Cleared Oct 01, 2003
CLS-2000 UNIT
K024133 · FLE
Dentsply Intl.
General Hospital · 289d
Cleared Oct 01, 2003
CYNOSURE SMART 2940D ER:YAG LASER
K031389 · GEX
Cynosure, Inc.
General & Plastic Surgery · 152d
Cleared Oct 01, 2003
SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
K031440 · GEX
Cynosure, Inc.
General & Plastic Surgery · 148d
Cleared Oct 01, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031523 · LFL
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 139d
Cleared Oct 01, 2003
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
K031922 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 100d
Cleared Oct 01, 2003
W.O.M. LASER U100PLUS
K032023 · GEX
W.O.M. World of Medicine AG
General & Plastic Surgery · 93d
Cleared Oct 01, 2003
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
K032072 · HWC
Arthrotek, Inc.
Orthopedic · 90d
Cleared Oct 01, 2003
PERIFIX CATHETER CONNECTOR
K032144 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 79d
Cleared Oct 01, 2003
APPOLLO 3 ALLOY
K032320 · EJT
Dentsply International
Dental · 65d
Cleared Oct 01, 2003
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K032705 · LXT
Hand Innovations, Inc.
Orthopedic · 29d
Cleared Oct 01, 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · HSB
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Oct 01, 2003
BIOSIGN STEAM-24 BIOLOGICAL INDICATOR
K032723 · FRC
Getinge USA, Inc.
General Hospital · 28d
Cleared Oct 01, 2003
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K032805 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 22d
Cleared Sep 30, 2003
EXTENDED RANGE HS CRP KIT, CAT NO:9200
K030044 · DCK
Reference Diagnostics, Inc.
Chemistry · 267d
Cleared Sep 30, 2003
VASCUPUNCTURE PICC GUIDEWIRE
K031652 · DQX
Neometrics, Inc.
Cardiovascular · 125d
Cleared Sep 30, 2003
SENOVA(R) BLOOD GLUCOSE MONITOR
K032076 · LFR
Chdiagnostics, LLC
Chemistry · 85d
Cleared Sep 30, 2003
TULIP COLORSWITCH
K032116 · ELW
Cavex Holland BV
Dental · 83d
Cleared Sep 30, 2003
PHEM-ALERT
K032161 · LNW
Femtek,Llc.
Chemistry · 77d
Cleared Sep 30, 2003
U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE
K032247 · MEG
U.S. Technologies, Inc.
General Hospital · 70d
Cleared Sep 30, 2003
ORION E ALLOY
K032316 · EJT
Dentsply Intl.
Dental · 64d
Cleared Sep 30, 2003
ORION GX ALLOY
K032317 · EJT
Dentsply Intl.
Dental · 64d