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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
51913–51936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2009
HI TECH IMPLANT, HT PHYSIO IMPLANT
K091913 · EKX
By Dental Srl
Dental · 122d
Cleared Oct 30, 2009
PALINDROME P HEMODIALYSIS CATHETER
K092205 · MSD
Covidien Lp, Formerly Registered AS...
Gastroenterology & Urology · 100d
Cleared Oct 30, 2009
BIODENTINE
K092251 · KIF
Septodont
Dental · 94d
Cleared Oct 30, 2009
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR,...
K092309 · KNS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 92d
Cleared Oct 30, 2009
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · LHI
Baxter Healthcare Corporation
General Hospital · 87d
Cleared CT Oct 30, 2009
SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
K092342 · NYV
The Smartpill Corporation
Gastroenterology & Urology · 87d
Cleared Oct 30, 2009
TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
K092403 · NHA
Zimmer Dental, Inc.
Dental · 85d
Cleared Oct 30, 2009
SPINAL FIXATION SYSTEM
K092536 · NKB
Lanx, Inc.
Orthopedic · 72d
Cleared Oct 30, 2009
DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX
K092547 · MUH
Dentimax
Radiology · 72d
Cleared Oct 30, 2009
MITS DICOM GATEWAY AND IMAGE MANAGER
K092581 · LLZ
Mitsmed Medical Instrument Technology...
Radiology · 70d
Cleared Oct 30, 2009
ELECSYS RUBELLA IGGA CALCHECK 5
K092585 · JJX
Roche Diagnostics
Microbiology · 67d
Cleared Oct 30, 2009
F.A.S.T. SYSTEM SED AND CXD
K092623 · QEW
Genesis Medical Interventional, Inc.
Cardiovascular · 65d
Cleared Oct 30, 2009
DIRECT DIGITIZER, REGIUS MODEL 210
K092717 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 57d
Cleared Oct 30, 2009
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
K093221 · DYH
Dentsply Intl., Inc.
Dental · 17d
Cleared Oct 30, 2009
INTEGRATED REGISTRATION
K093234 · LLZ
GE Medical Systems SCS
Radiology · 15d
Cleared Oct 30, 2009
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
K093300 · KGO
Cardinal Health, Inc.
General Hospital · 9d
Cleared Oct 29, 2009
IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
K083080 · DHR
Sqi Diagnostics Systems
Immunology · 378d
Cleared Oct 29, 2009
EXELO2, MODEL 4010
K090639 · ONG
Quantel Derma GmbH
General & Plastic Surgery · 233d
Cleared Oct 29, 2009
QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH...
K090689 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 227d
Cleared Oct 29, 2009
ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
K091290 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 181d
Cleared Oct 29, 2009
TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
K091761 · BTR
Teleflexmedical, Inc.
Anesthesiology · 135d
Cleared Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
K091916 · DAP
Siemens Healthcare Diagnostics
Hematology · 121d
Cleared Oct 29, 2009
MONOLISA ANTI-HAV IGM EIA
K092353 · LOL
Bio-Rad Laboratories, Inc.
Microbiology · 86d
Cleared Oct 29, 2009
MONOLISA ANTI-HAV EIA
K092355 · LOL
Bio-Rad Laboratories, Inc.
Microbiology · 86d