Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
64537–64560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 2005
EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
K043520 · CAW
Emg Technology Co., Ltd.
Anesthesiology · 305d
Cleared Oct 21, 2005
SENTINEL CERULOPLASMIN
K051456 · JFR
Sentinel Ch. Srl
Immunology · 141d
Cleared Oct 21, 2005
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
K051579 · DKZ
Immunalysis Corporation
Toxicology · 129d
Cleared Oct 21, 2005
IN6 SAFETY SYRINGE, MODEL 3ML
K051800 · MEG
In6 Incuvestor, Inc.
General Hospital · 108d
Cleared Oct 21, 2005
TGO SPRAY
K051812 · LFD
Laboratoires Carilene S.A.S.
Dental · 108d
Cleared Oct 21, 2005
DIAGNODENT
K051909 · NBL
Kavo America
Dental · 99d
Cleared Oct 21, 2005
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K051948 · KRR
Howmedica Osteonics Corp.
Orthopedic · 95d
Cleared Oct 21, 2005
MODUS IMF SCREWS 2.0
K052061 · DZE
Medartis, Inc.
Dental · 84d
Cleared Oct 21, 2005
PINNACLE CONSTRAINED ACETABULAR LINERS
K052079 · KWZ
DePuy Orthopaedics, Inc.
Orthopedic · 80d
Cleared Oct 21, 2005
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184,...
K052104 · GEI
Conmed Corporation
General & Plastic Surgery · 79d
Cleared Oct 21, 2005
GEM PREMIER 3000
K052121 · CGA
Instrumentation Laboratory CO
Chemistry · 77d
Cleared Oct 21, 2005
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
K052161 · MKJ
Cardiac Science, Inc.
Cardiovascular · 73d
Cleared Oct 21, 2005
DEPUY CAS HIP INSTRUMENTATION
K052178 · HAW
DePuy Orthopaedics, Inc.
Neurology · 72d
Cleared Oct 21, 2005
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
K052286 · GBX
The Catheter Exchange, Inc.
General & Plastic Surgery · 60d
Cleared Oct 21, 2005
SPIDER CERVICAL PLATING (SCP) SYSTEM
K052292 · KWQ
X-Spine Systems, Inc.
Orthopedic · 59d
Cleared Oct 21, 2005
SHOULDER NAIL PLATE
K052294 · HRS
Hand Innovations, LLC
Orthopedic · 59d
Cleared Oct 21, 2005
AVANTE LED CURING UNIT, MODEL N44
K052349 · EBZ
Pentron Clinical Technologies
Dental · 53d
Cleared Oct 21, 2005
MULTIPLE RESIN TOOTH BONDING AGENT
K052501 · KLE
Cosmedent, Inc.
Dental · 38d
Cleared Oct 21, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K052609 · NKB
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Oct 21, 2005
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052631 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 25d
Cleared Oct 21, 2005
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 25d
Cleared Oct 21, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734 · KWP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 21, 2005
CONCORDE VBR SPINAL SYSTEM
K052746 · MQP
Depuy Spine, Inc.
Orthopedic · 21d
Cleared Oct 21, 2005
ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000
K052857 · GEI
Senorx, Inc.
General & Plastic Surgery · 10d