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
61081–61104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2006
THE 5.0 X 6.0MM DENTAL IMPLANT
K062044 · DZE
Bicon, Inc.
Dental · 125d
Cleared Nov 21, 2006
PORTABLE OXYGEN GENERATOR SYSTEM
K062153 · CAW
Molecular Products , Ltd.
Anesthesiology · 117d
Cleared Nov 21, 2006
ENAMEL PRO
K062166 · EJR
Premier Dental Products Co.
Dental · 116d
Cleared Nov 21, 2006
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
K062183 · LRM
The Binding Site, Ltd.
Immunology · 113d
Cleared Nov 21, 2006
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S
K062212 · FRO
Anacapa Technologies, Inc.
General & Plastic Surgery · 112d
Cleared Nov 21, 2006
AESCULAP PNEUMATIC KERRISON
K062413 · HAD
Aesculap, Inc.
Neurology · 96d
Cleared Nov 21, 2006
FLEXPEN NEEDLE
K062500 · FMI
Novo Nordisk, Inc.
General Hospital · 88d
Cleared Nov 21, 2006
LONGPORT EPISCAN, MODEL-I-200
K062571 · IYO
Longport, Inc.
Radiology · 82d
Cleared Nov 21, 2006
TELEMEDICINE SYSTEM MODEL VMS-01
K062662 · DRG
Medic4all (Israel) , Ltd.
Cardiovascular · 75d
Cleared Nov 21, 2006
ENAMEL PRO VARNISH
K062683 · LBH
Premier Dental Products Co.
Dental · 74d
Cleared Nov 21, 2006
GREENTON ECOLITE IPL SYSTEM
K062721 · GEX
Greenton (London) , Ltd.
General & Plastic Surgery · 70d
Cleared Nov 21, 2006
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
K062781 · IXI
Symtium Corporation
Radiology · 64d
Cleared Nov 21, 2006
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
K062822 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 62d
Cleared Nov 21, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML
K062945 · LON
Becton, Dickinson & CO
Microbiology · 54d
Cleared Nov 21, 2006
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL
K063161 · GEI
Leonhard Lang GmbH
General & Plastic Surgery · 35d
Cleared Nov 21, 2006
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
K063178 · FTM
C.R. Bard, Inc.
General & Plastic Surgery · 33d
Cleared Nov 21, 2006
MODIFICATION TO BIOMARC TISSUE MARKER
K063193 · NEU
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 32d
Cleared Nov 21, 2006
ON-Q INTRODUCERS
K063234 · BSO
I-Flow Corp.
Anesthesiology · 27d
Cleared Nov 21, 2006
SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR
K063240 · LJS
C.R. Bard, Inc.
General Hospital · 26d
Cleared Nov 21, 2006
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
K063291 · FLL
Choice Smart Health Care Co. , Ltd.
General Hospital · 20d
Cleared Nov 21, 2006
M3
K063333 · FSY
Mavig GmbH
General & Plastic Surgery · 15d
Cleared Nov 21, 2006
EXCELART VANTAGE ATLAS, MODEL MRT-1503
K063361 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 21, 2006
BIOAGGREGATE
K063422 · KIF
Innovative Bioceramix, Inc.
Dental · 8d
Cleared Nov 21, 2006
SMITH & NEPHEW RF CANNULAE
K063467 · GXI
Smith & Nephew, Inc.
Neurology · 28d