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
80761–80784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · LDP
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 11, 2000
C.T.M. POWER CHAIR, MODEL HS-5600
K002983 · ITI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 16d
Cleared Oct 10, 2000
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
K000927 · LFL
Misonix, Inc.
General & Plastic Surgery · 202d
Cleared Oct 10, 2000
Q-LUX PLASMA 100 LIGHT CURE UNIT
K001719 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 127d
Cleared Oct 10, 2000
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
K002104 · IKN
Maryrose Cusimano, Ph.D. & Scott Zeff
Neurology · 90d
Cleared Oct 10, 2000
MENICON PROGENT REMOVER
K002140 · MRC
Menicon Co, Ltd.
Ophthalmic · 85d
Cleared Oct 10, 2000
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
K002152 · MQN
KLS-Martin L.P.
Dental · 85d
Cleared Oct 10, 2000
ATOM INFA WARMER V-505
K002355 · FMT
Atom Medical Corp
General Hospital · 69d
Cleared Oct 10, 2000
MODEL 4815 ADAPTER
K002496 · DTN
Pace Medical
Cardiovascular · 57d
Cleared Oct 10, 2000
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · DTC
Pace Medical
Cardiovascular · 57d
Cleared Oct 10, 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · JAK
GE Medical Systems
Radiology · 15d
Cleared Oct 06, 2000
ACTICOAT 7 DRESSING
K001519 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 143d
Cleared Oct 06, 2000
RESUSCI INFLATE-A-SHIELD CPR BARRIER
K001742 · CBP
Laerdal Medical Corp.
Anesthesiology · 120d
Cleared Oct 06, 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082 · KWP
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared Oct 06, 2000
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
K002094 · ESW
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Oct 06, 2000
SPL CRIMP SYSTEM
K002110 · JDQ
Pioneer Surgical Technology
Orthopedic · 86d
Cleared Oct 06, 2000
PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
K002228 · GEX
Paradigm Medical Industries, Inc.
General & Plastic Surgery · 74d
Cleared Oct 06, 2000
EEG SPIKE AND EVENT DETECTOR MODULE
K002332 · OMB
Excel Tech. , Ltd.
Neurology · 66d
Cleared Oct 06, 2000
ADVANTAGE DRIVE SYSTEM
K002523 · HBC
Linvatec Corp.
Neurology · 52d
Cleared Oct 06, 2000
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
K002557 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 50d
Cleared Oct 06, 2000
INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
K002592 · KWQ
Interpore Cross Intl.
Orthopedic · 46d
Cleared Oct 06, 2000
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · JDS
Synthes (Usa)
Orthopedic · 35d
Cleared Oct 06, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K002939 · DQA
Masimo Corp.
Anesthesiology · 15d
Cleared Oct 06, 2000
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · KWT
Biomet, Inc.
Orthopedic · 10d