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
72505–72528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2003
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
K030103 · MNI
Depuyacromed
Orthopedic · 23d
Cleared Feb 05, 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · LWJ
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Feb 04, 2003
DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
K014001 · MQN
Oral Osteodistraction, L.P.
Dental · 427d
Cleared Feb 04, 2003
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
K022364 · HAW
Orthosoft, Inc.
Neurology · 197d
Cleared Feb 04, 2003
HTS COIL
K022863 · MOS
Jockey Club Mri Engineering Center
Radiology · 160d
Cleared Feb 04, 2003
TRUTEK SELECT MODEL TT-1001
K023510 · FLL
Trutek, Inc.
General Hospital · 106d
Cleared Feb 04, 2003
SNAP KOVER, MODEL 01-2020
K023540 · MMP
Valumed
General Hospital · 105d
Cleared Feb 04, 2003
STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K023715 · LYY
Starmatrix Sdn Bhd
General Hospital · 91d
Cleared Feb 04, 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP...
K023828 · DCK
Kamiya Biomedical Co.
Immunology · 78d
Cleared Feb 04, 2003
AIROCIDE TI02
K023830 · FRA
Kes Science & Technology, Inc.
General Hospital · 78d
Cleared Feb 04, 2003
GE DISCOVERY LS SYSTEM
K023988 · KPS
GE Medical Systems
Radiology · 64d
Cleared Feb 04, 2003
PANORAMA ENHANCEMENTS
K024042 · LNH
Philips Medical Systems, Inc.
Radiology · 60d
Cleared Feb 04, 2003
INFINION SOFTWARE FEATURES
K024066 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 57d
Cleared Feb 04, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K024187 · MOS
Usa Instruments, Inc.
Radiology · 47d
Cleared Feb 04, 2003
UP-DF500 FILMSTATION DIGITAL FILM IMAGER
K024188 · LMC
Sony Medical Systems
Radiology · 47d
Cleared Feb 03, 2003
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
K020318 · FRO
Scivolutions, Inc.
General & Plastic Surgery · 369d
Cleared Feb 03, 2003
RADIUS MICRO SNARE
K022201 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 213d
Cleared Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · FRO
Coloplast Corp.
General & Plastic Surgery · 194d
Cleared Feb 03, 2003
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
K022483 · FRO
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery · 189d
Cleared Feb 03, 2003
WATERLASE FOR APICOECTOMY
K022803 · MXF
Biolase Technology, Inc.
Dental · 164d
Cleared Feb 03, 2003
REPROCESSED EXTERNAL FIXATION DEVICE
K023714 · KTT
Alliance Medical Corp.
Orthopedic · 90d
Cleared Feb 03, 2003
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT
K023724 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Feb 03, 2003
HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247
K023725 · GDW
Marina Medical Instruments, Inc.
General & Plastic Surgery · 89d
Cleared Feb 03, 2003
SIASCOPE II
K023729 · PSN
Astron Clinica Limited
General & Plastic Surgery · 89d