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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
70801–70824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2003
INTRALASE FS LASER
K031960 · GEX
Intra Lase Corp.
General & Plastic Surgery · 96d
Cleared Sep 29, 2003
ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00,...
K031974 · HIH
Asap Endoscopic Products GmbH
Obstetrics & Gynecology · 95d
Cleared Sep 29, 2003
ENVISION
K032042 · DYH
Sybron Dental Specialties, Inc.
Dental · 90d
Cleared Sep 29, 2003
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
K032232 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240 · MID
The Binding Site, Ltd.
Immunology · 70d
Cleared Sep 29, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE...
K032275 · LON
Becton, Dickinson & CO
Microbiology · 68d
Cleared Sep 26, 2003
MAKY 21.1 DIALYZER REPROCESSING SYSTEM
K024076 · LIF
Hdc Maquinolas, LLC
Gastroenterology & Urology · 290d
Cleared Sep 26, 2003
ATAC TOTAL BILIRUBIN REAGENT
K030014 · CIG
Elan Diagnostics
Chemistry · 267d
Cleared Sep 26, 2003
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
K031308 · DBM
Rhigene, Inc.
Immunology · 155d
Cleared Sep 26, 2003
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
K032151 · JWH
Depuy, Inc.
Orthopedic · 74d
Cleared Sep 26, 2003
COULTER LH 750 HEMATOLOGY ANALYZER
K032342 · GKZ
Beckman Coulter, Inc.
Hematology · 59d
Cleared Sep 26, 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
K032680 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 28d
Cleared Sep 26, 2003
RAYCELL
K032684 · MOT
Mds Nordion
Radiology · 28d
Cleared Sep 26, 2003
DW 296 #15 SOLDER
K032715 · EJT
Ivoclar Vivadent, Inc.
Dental · 24d
Cleared Sep 26, 2003
IRRIGATION SETS
K032832 · HRX
Vital Concepts, Inc.
Orthopedic · 15d
Cleared Sep 26, 2003
CELON ENT SYSTEM
K032838 · GEI
Celon AG Medical Instruments
General & Plastic Surgery · 15d
Cleared Sep 26, 2003
EXCISOR BIOPTOME, MODEL 01-0004
K032847 · KNW
Acueity, Inc.
Gastroenterology & Urology · 14d
Cleared Sep 26, 2003
ULTRACROWN 75 ALLOY
K032851 · EJT
Dentsply International
Dental · 14d
Cleared Sep 26, 2003
MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
K032892 · EBI
Dentsply Intl.
Dental · 9d
Cleared Sep 25, 2003
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
K030393 · MXK
Haag-Streit Holding AG
Ophthalmic · 232d
Cleared Sep 25, 2003
RINSPIRATION SYSTEM
K031485 · DQO
Kerberos Proximal Solutions
Cardiovascular · 136d
Cleared Sep 25, 2003
SENTINOL NITINOL BILLARY STENT SYSTEM
K032025 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Sep 25, 2003
BLINK CL LUBRICANT EYE DROPS
K032030 · LPN
Advanced Medical Optics, Inc.
Ophthalmic · 86d
Cleared Sep 25, 2003
RATTAN IMACS BY RATTAN INFORMATION CORPORATION
K032176 · LLZ
Rattan Information Corporation
Radiology · 71d