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
90265–90288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1998
PULPDENT CAVITY VARNISH
K974398 · LBH
Pulpdent Corp.
Dental · 89d
Cleared Feb 18, 1998
ORTHOPLAN
K974406 · HWT
Ortho-Graphics, Inc.
Orthopedic · 89d
Cleared Feb 18, 1998
RAPET CRP
K974429 · DCN
Stanbio Laboratory
Immunology · 86d
Cleared Feb 18, 1998
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
K974487 · EIA
Asi Medical, Inc.
Dental · 84d
Cleared Feb 18, 1998
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
K974537 · KTT
Synthes (Usa)
Orthopedic · 77d
Cleared Feb 18, 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K974573 · KWP
Depuy, Inc.
Orthopedic · 72d
Cleared Feb 18, 1998
PERCSCOPE MODEL 2600
K974579 · HRX
Clarus Medical Systems, Inc.
Orthopedic · 72d
Cleared Feb 18, 1998
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
K980226 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 27d
Cleared Feb 18, 1998
ACRI R NEEDLE
K980248 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 26d
Cleared Feb 18, 1998
RELIEFBAND
K980333 · GZJ
Woodside Biomedical, Inc.
Neurology · 21d
Cleared Feb 18, 1998
MANAN LIVER BIOPSY KIT
K980452 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 13d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
K971169 · LSR
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
K971170 · LSR
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 17, 1998
OBSERVER * CENTRAL STATION
K972498 · DSI
Johnson & Johnson Medical, Inc.
Cardiovascular · 229d
Cleared Feb 17, 1998
REGANES RADIONUCLIDE SEED MAGAZINE
K972554 · IWJ
Avid N.I.T., Inc.
Radiology · 224d
Cleared Feb 17, 1998
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
K973483 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 155d
Cleared Feb 17, 1998
INFUSION DYNAMICS POWER INFUSER
K974074 · KZD
Infusion Dynamics, Inc.
General Hospital · 111d
Cleared Feb 17, 1998
WIELISA MPO ANCA TEST SYSTEM
K974166 · MOB
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA PR-3 ANCA TEST SYSTEM
K974167 · MOB
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA ANTI-GBM TEST SYSTEM
K974169 · DBL
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
K974355 · OWB
Ge Dec Medical Systems
Radiology · 90d
Cleared Feb 17, 1998
RAPET RF
K974370 · DHR
Stanbio Laboratory
Immunology · 89d
Cleared Feb 17, 1998
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
K974505 · DBF
Alfa Biotech (Uk) , Ltd.
Immunology · 78d
Cleared Feb 17, 1998
TRUE VISION, TRUE VISION II
K974542 · EIA
Medical Dynamics, Inc.
Dental · 76d