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
72673–72696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 17, 2003
AVANT GUARDIAN 101
K024018 · KZE
Avant Medical Corporation
General Hospital · 44d
Cleared Jan 17, 2003
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
K024020 · FTC
Theralight, Inc.
General & Plastic Surgery · 43d
Cleared Jan 17, 2003
SURESET 3.0 ML RESERVOIR, MODEL 24-103
K024056 · FRN
Applied Diabetes Research, Incorporated
General Hospital · 39d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
K024218 · LKJ
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
K024220 · DHN
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
K024232 · LKJ
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
ULTRASOUND SCANNER, TYPE 2400
K024236 · IYN
B & K Medical A/S
Radiology · 25d
Cleared Jan 17, 2003
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K024366 · FZP
Coalescent Surgical
General & Plastic Surgery · 17d
Cleared Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371...
K030012 · JHX
Beckman Coulter, Inc.
Chemistry · 15d