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
77905–77928 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2001
CODMAN BACTISEAL CATHETERS
K003322 · HCA
Codman & Shurtleff, Inc.
Neurology · 342d
Cleared Oct 01, 2001
EXPRESSSUITE
K011049 · LMA
Vidar Systems Corp.
Radiology · 178d
Cleared Oct 01, 2001
XLTEK LED GOGGLES, MODEL LED-01
K011794 · GWE
Excel Tech. , Ltd.
Neurology · 115d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · JDR
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Oct 01, 2001
CYTOFLEX
K012144 · LYC
Unicare Biomedical, Inc.
Dental · 83d
Cleared Oct 01, 2001
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105,...
K012176 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 81d
Cleared Oct 01, 2001
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
K012227 · IYE
Oncology Data Systems, Inc.
Radiology · 77d
Cleared Oct 01, 2001
DOSERIGHT
K012238 · JAK
Philips Medical Systems North America...
Radiology · 76d
Cleared Oct 01, 2001
SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
K012283 · FMI
Safegard Medical Products, Inc.
General Hospital · 73d
Cleared Oct 01, 2001
BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE...
K012335 · JOJ
Albert Browne , Ltd.
General Hospital · 69d
Cleared Oct 01, 2001
BAYER ADVIA SYSTEM
K012340 · JMO
Bayer Corp.
Chemistry · 69d
Cleared Oct 01, 2001
NAVIGUS II TRAJECTORY GUIDE
K012366 · HAW
Image-Guided Neurologics, Inc.
Neurology · 67d
Cleared Oct 01, 2001
BIS/EEG MODULE
K012466 · OLW
General Electric Medical Systems...
Neurology · 61d
Cleared Oct 01, 2001
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT...
K012709 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 48d
Cleared Oct 01, 2001
CTS-485 ULTRASOUND IMAGING SYSTEM
K012772 · IYO
Shantou Institute of Ultrasonic...
Radiology · 45d
Cleared Oct 01, 2001
POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
K012786 · LZA
Shamrock Manufacturing Company
General Hospital · 42d
Cleared Oct 01, 2001
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT...
K012876 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 35d
Cleared Oct 01, 2001
SONICWAVE SONIC PLAQUE REMOVER
K012914 · JEQ
Homedics, Inc.
Dental · 32d
Cleared Oct 01, 2001
BELLEGLASS HP ENAMEL 2
K013007 · EBF
Sybron Dental Specialties, Inc.
Dental · 25d
Cleared Oct 01, 2001
EXHALE PROBE
K013111 · EOQ
Broncus Technologies, Inc.
Radiology · 13d
Cleared Sep 28, 2001
OMNICARE DENTAL IMPLANT SYSTEM
K000035 · DZE
Omnicare Dental Implant Center
Dental · 631d
Cleared Sep 28, 2001
MIS IMPLANT SYSTEM DECIVE
K003191 · DZE
Mis Implants Technologies , Ltd.
Dental · 353d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 295d
Cleared Sep 28, 2001
UNIVERSAL DENTAL COPING (UDC)
K010467 · DZE
Paxmed International
Dental · 224d