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
62089–62112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2006
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
K061522 · EGJ
Activatek, Inc.
Physical Medicine · 60d
Cleared Aug 01, 2006
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
K061762 · KKX
Cardinal Health, Inc.
General Hospital · 40d
Cleared Aug 01, 2006
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K061843 · DQY
St Jude Medical
Cardiovascular · 32d
Cleared Aug 01, 2006
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
K061857 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 32d
Cleared Aug 01, 2006
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE...
K061882 · JWH
Zimmer, Inc.
Orthopedic · 29d
Cleared Aug 01, 2006
FUSION
K061912 · INI
Burke, Inc.
Physical Medicine · 26d
Cleared Jul 31, 2006
ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE
K053654 · NHA
Atlantis Components, Inc.
Dental · 213d
Cleared Jul 31, 2006
BRIGIT SURGICAL DEVICE
K060556 · HAW
Zimmer, Inc.
Neurology · 151d
Cleared Jul 31, 2006
NC-STAT
K060584 · JXE
Neurometrix, Inc.
Neurology · 146d
Cleared Jul 31, 2006
COOLTOUCH VARIA ND:YAG LASER SYSTEM
K060966 · GEX
Cooltouch, Inc.
General & Plastic Surgery · 115d
Cleared Jul 31, 2006
DIASORIN LIAISON TREPONEMA ASSAY
K061247 · LIP
DiaSorin, Inc.
Microbiology · 89d
Cleared Jul 31, 2006
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
K061266 · OAT
Ortho Organizers, Inc.
Dental · 87d
Cleared Jul 31, 2006
G-LIX TISSUE GRASPER
K061268 · HET
Usgi Medical
Obstetrics & Gynecology · 87d
Cleared Jul 31, 2006
INTUITION INFUSION SETS
K061374 · FPA
Unomedical A/S
General Hospital · 75d
Cleared Jul 31, 2006
CELSITE/ CELSITE CONCEPT, ACCESS PORTS
K061424 · LJT
Aesculap, Inc.
General Hospital · 69d
Cleared Jul 31, 2006
SPI ART ABUTMENTS
K061807 · NHA
Thommen Medical AG
Dental · 34d
Cleared Jul 31, 2006
NXSTAGE CARTRIDGE EXPRESS
K061837 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 32d
Cleared Jul 31, 2006
SURPASS
K061981 · KLE
Apex Dental Materials, Inc.
Dental · 18d
Cleared Jul 31, 2006
FLEXVIEW SYSTEM
K062050 · GCJ
Boston Scientific
General & Plastic Surgery · 11d
Cleared Jul 31, 2006
LMT NOMAG IC 3.0
K062052 · FPL
Lmt Lammers Medical Technology GmbH
General Hospital · 11d
Cleared Jul 28, 2006
FEMECC ENDOCERVICAL CURETTE
K060320 · PCF
Femspec LLC
Obstetrics & Gynecology · 170d
Cleared Jul 28, 2006
ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
K060354 · JXM
Acro Biotech, LLC
Toxicology · 165d
Cleared Jul 28, 2006
CALYPSO 4D LOCALIZATION SYSTEM
K060906 · IYE
Calypso Medical Technologies, Inc.
Radiology · 116d
Cleared Jul 28, 2006
BIOPSY MEDIUM, MODEL REF 1062
K060983 · MQL
Medicult A/S
Obstetrics & Gynecology · 109d