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
73177–73200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2003
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI...
K023009 · DFH
The Binding Site, Ltd.
Immunology · 134d
Cleared Jan 21, 2003
FREELITE HUMAN LAMBDA FREE KIT
K023131 · DEH
The Binding Site, Ltd.
Immunology · 134d
Cleared Jan 21, 2003
UCC DENTAL MATERIAL
K023790 · EJT
Precious Chemicals U.S.A., Inc.
Dental · 69d
Cleared Jan 21, 2003
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000...
K023795 · JXN
Lin-Zhi International, Inc.
Toxicology · 69d
Cleared Jan 21, 2003
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...
K030074 · JIX
Cliniqa Corporation
Immunology · 13d
Cleared Jan 17, 2003
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
K022035 · JEY
Osteomedics, Inc.
Dental · 210d
Cleared Jan 17, 2003
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K023138 · FRO
Hydrofera, LLC
General & Plastic Surgery · 119d
Cleared Jan 17, 2003
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
K023528 · JWH
Centerplus Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
K023531 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
BARCO MEDIS 5MP2 AURA
K023533 · LLZ
Barco N.V.
Radiology · 88d
Cleared Jan 17, 2003
TRIPTER X-1 COMPACT DUET
K023535 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 88d
Cleared Jan 17, 2003
MAXIM ACCEL KNEE SYSTEM
K023546 · JWH
Biomet, Inc.
Orthopedic · 87d
Cleared Jan 17, 2003
STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM
K023580 · DZE
Sterngold
Dental · 85d
Cleared Jan 17, 2003
SILVERLON ADHESIVE STRIP
K023609 · FRO
Argentum International, LLC
General & Plastic Surgery · 81d
Cleared Jan 17, 2003
VITIQUE SYSTEM
K023649 · EMA
Dmg USA, Inc.
Dental · 79d
Cleared Jan 17, 2003
MAXONE IV FLUID/BLOOD WARMER, MODEL 102
K023653 · LGZ
Automatic Medical Technologies, Inc.
General Hospital · 79d
Cleared Jan 17, 2003
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
K023689 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 77d
Cleared Jan 17, 2003
VISORB SWIFT
K023710 · GAM
Cp Medical
General & Plastic Surgery · 74d
Cleared Jan 17, 2003
GLUCOSE-SL-C ASSAY, MODEL 257-30
K023739 · CFR
Diagnostic Chemicals , Ltd.
Chemistry · 71d
Cleared Jan 17, 2003
SCULPTURE PLUS NANO-HYBRID COMPOSITE
K023742 · EBF
Pentron Laboratory Technologies
Dental · 71d
Cleared Jan 17, 2003
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
K023745 · DTX
Sechrist Industries, Inc.
Cardiovascular · 71d
Cleared Jan 17, 2003
FLASH-LITE II LED DENTAL CURING LIGHT
K023748 · EBZ
Discus Dental, Inc.
Dental · 70d
Cleared Jan 17, 2003
BIPOLAR FORCEPS
K023813 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 63d
Cleared Jan 17, 2003
MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
K023892 · BSN
Millipore Corp.
Anesthesiology · 56d