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
94681–94704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1997
RUSCH SUPRAPUBIC TRAY
K970021 · KOB
Rusch, Inc.
Gastroenterology & Urology · 35d
Cleared Feb 06, 1997
AS/3 ESTPR MODULE
K953175 · MLD
Datex Division Instrumentarium Corp.
Cardiovascular · 580d
Cleared Feb 06, 1997
COBE HEMODYNAMIC RECIRCULATION MONITOR
K954003 · MQS
Cobe Renal Care, Inc.
Gastroenterology & Urology · 531d
Cleared Feb 06, 1997
METALLIC SPHERICAL CMC IMPLANT
K960534 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 365d
Cleared Feb 06, 1997
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
K960659 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 356d
Cleared Feb 06, 1997
RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
K961498 · HRS
Howmedica, Inc.
Orthopedic · 294d
Cleared Feb 06, 1997
MLC FIT
K962335 · IYE
Impac Medical Systems, Inc.
Radiology · 234d
Cleared Feb 06, 1997
MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
K962603 · DQA
Masimo Corp.
Anesthesiology · 219d
Cleared Feb 06, 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 209d
Cleared Feb 06, 1997
M AND R REUSABLE ELECTRODES (MULTIPLE)
K963125 · GZJ
M & R Mfg., Inc.
Neurology · 178d
Cleared Feb 06, 1997
OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
K963139 · DDD
Olympus America, Inc.
Immunology · 178d
Cleared Feb 06, 1997
TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
K963302 · ITX
Tayman Medical, Inc.
Radiology · 168d
Cleared Feb 06, 1997
TARGET MYOGLOBIN TEST
K963680 · DDR
Texas Immunology, Inc.
Immunology · 143d
Cleared Feb 06, 1997
LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
K963741 · HRS
Howmedica Leibinger, Inc.
Orthopedic · 142d
Cleared Feb 06, 1997
SYSMEX CA-6000
K964139 · GKP
Dade Intl., Inc.
Hematology · 114d
Cleared Feb 06, 1997
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
K964401 · FMT
Ludlow Technical Products
General Hospital · 94d
Cleared Feb 06, 1997
OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964493 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC
K964496 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CERALAS DIODE LASER SYSTEM (CERALAS D15)
K964497 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 90d
Cleared Feb 06, 1997
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964501 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964512 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
DEPUY DUPONT PHANTOM SUTURE ANCHOR
K964521 · MAI
Depuy, Inc.
Orthopedic · 86d
Cleared Feb 06, 1997
ULTRAFERA WOUND DRESSING
K964614 · KMF
American White Cross, Inc.
General & Plastic Surgery · 80d
Cleared Feb 06, 1997
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
K964623 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 80d