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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36529–36552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN...
K140050 · LZA
Hartalega Sdn Bhd
General Hospital · 246d
Cleared Sep 12, 2014
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
K140367 · KGN
Harbor Medtech, Inc.
General & Plastic Surgery · 210d
Cleared Sep 12, 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
K140608 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 186d
Cleared Sep 12, 2014
ARTIMES BALLOON DILATATION CATHETER
K141025 · LOX
Brosmed Medical
Cardiovascular · 144d
Cleared Sep 12, 2014
SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON...
K141033 · OMP
Argentum Medical, LLC
General & Plastic Surgery · 143d
Cleared Sep 12, 2014
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
K141235 · LZO
Microport Orthopedics, Inc.
Orthopedic · 122d
Cleared Sep 12, 2014
WHISPERJECT AUTOINJECTOR
K141384 · KZH
Scandinavian Health Limited
General Hospital · 108d
Cleared Sep 12, 2014
ZVPLASTY
K141419 · NDN
Zavation, LLC
Orthopedic · 106d
Cleared Sep 12, 2014
ORTHODONTIC ACRYLIC (NOT FINALIZED)
K141439 · EBI
Bisco, Inc.
Dental · 102d
Cleared Sep 12, 2014
DX-D IMAGING PACKAGE
K141602 · MQB
Agfa Healthcare N.V.
Radiology · 88d
Cleared Sep 12, 2014
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25,...
K141949 · HWC
Aap Implantate AG
Orthopedic · 56d
Cleared Sep 12, 2014
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
K141971 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Sep 12, 2014
MYLABSEVEN, MYLABALPHA
K142008 · IYN
Esaote, S.P.A.
Radiology · 51d
Cleared Sep 12, 2014
MYLABGAMMA
K142077 · IYN
Esaote, S.P.A.
Radiology · 43d
Cleared Sep 12, 2014
C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES
K142134 · HTY
Conmed Corporation, Largo
Orthopedic · 39d
Cleared Sep 12, 2014
Pilot Pro Diode Laser
K142223 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
Pilot Elite Diode Laser
K142225 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
Pilot Ultra Diode Laser
K142226 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
LARIAT sulture Delivery Device
K142241 · GAT
Sentreheart, Inc.
General & Plastic Surgery · 30d
Cleared Sep 11, 2014
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE...
K134019 · FIE
Nxstage Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Sep 11, 2014
CRANE ACRYLIC HERBST APPLIANCE
K140429 · LRK
Crane Dental Laboratory, Inc.
Dental · 204d
Cleared Sep 11, 2014
TABLO CARTRIDGE
K140841 · FJK
Home Dialysis Plus
Gastroenterology & Urology · 162d
Cleared Sep 11, 2014
RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
K140991 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 147d
Cleared Sep 11, 2014
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K141079 · OOE
Optimedica Corporation
Ophthalmic · 139d