FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
70297–70320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 25, 2003
PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
K032248 · IYE
Aktina Medical Physics Corp.
Radiology · 65d
Cleared Sep 25, 2003
ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105...
K032355 · EHD
Dentsply Gendex
Radiology · 57d
Cleared Sep 25, 2003
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
K032497 · HCG
Micro Therapeutics, Inc.
Neurology · 43d
Cleared Sep 25, 2003
EXOMIO, MODEL 2.0 SP1
K032550 · KPQ
Medcom GmbH
Radiology · 38d
Cleared Sep 25, 2003
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
K032591 · DQY
NuMED, Inc.
Cardiovascular · 34d
Cleared Sep 25, 2003
HRK-63-8 KNEE ARRAY COIL
K032633 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Sep 24, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030187 · NLH
Alliance Medical, Inc.
Cardiovascular · 246d
Cleared Sep 24, 2003
HEMAPROMPT GASTRIC
K031356 · KHE
Aerscher Diagnostics
Hematology · 166d
Cleared Sep 24, 2003
GI SUPPLY BILIARY STENT
K031360 · FGE
Gi Supply
Gastroenterology & Urology · 147d