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
89329–89352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1998
RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM
K981346 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 87d
Cleared Jul 10, 1998
MICROCOOL SURGICAL GOWN
K981393 · FYA
Kimberly-Clark Corp.
General Hospital · 84d
Cleared Jul 10, 1998
HEART CATH TRAY, STERILE, DISPOSABLE
K981441 · DQO
Trinity Laboratories, Inc.
Cardiovascular · 80d
Cleared Jul 10, 1998
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
K981464 · KNF
Omnitech Systems, Inc.
Obstetrics & Gynecology · 78d
Cleared Jul 10, 1998
TEMPO III
K981509 · LGZ
Medical Products, Inc.
General Hospital · 73d
Cleared Jul 10, 1998
PRILANE
K981524 · EIH
Gresco Products, Inc.
Dental · 73d
Cleared Jul 10, 1998
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER...
K981698 · MOI
Chiron Corp.
Immunology · 57d
Cleared Jul 10, 1998
PERMACEM AUTOMIX LUTING CEMENT SYSTEM
K981813 · EBF
Foremost Dental Mfg., Inc.
Dental · 49d
Cleared Jul 10, 1998
CONVERTORS TRILAMINATE DRAPES
K981818 · KKX
Allegiance Healthcare Corp.
General Hospital · 49d
Cleared Jul 10, 1998
FLOWABLE COMPOSITE
K981965 · EMA
Dentsply Intl.
Dental · 36d
Cleared Jul 09, 1998
TAKA ANEURYSM CLIP
K972750 · HCH
V. Mueller Neuro/Spine
Neurology · 351d
Cleared Jul 09, 1998
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
K974655 · KOJ
Prep Technology Corp.
Dental · 206d
Cleared Jul 09, 1998
SINGLE CHANNEL BALLOON CANNULA
K974801 · HDP
Conkin Surgical Instruments , Ltd.
Obstetrics & Gynecology · 199d
Cleared Jul 09, 1998
MITYVAC
K980212 · HDB
Prism Technologies, Inc.
Obstetrics & Gynecology · 169d
Cleared Jul 09, 1998
LASER LANCET LB100
K980538 · GEX
Transmedica Intl., Inc.
General & Plastic Surgery · 148d
Cleared Jul 09, 1998
TITANIUM PEG SYSTEM
K980822 · MQU
Fci Ophthalmics, Inc.
Ophthalmic · 128d
Cleared Jul 09, 1998
SURGIN KIT
K980849 · MSR
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 154d
Cleared Jul 09, 1998
MAGNATEK C-300
K981310 · GEI
Magna Advanced Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jul 09, 1998
SEQUENCER
K981313 · IYE
Impac Medical Systems, Inc.
Radiology · 90d
Cleared Jul 09, 1998
NAVITRACK
K981315 · HAW
Orthosoft, Inc.
Neurology · 90d
Cleared Jul 09, 1998
ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES
K981350 · GEX
Xintec Corporation
General & Plastic Surgery · 86d
Cleared Jul 09, 1998
CERMAX300 LIGHTSOURCE
K981469 · FSS
Cuda Products Co.
General & Plastic Surgery · 77d
Cleared Jul 09, 1998
MENTOR PATHWAY INTRODUCER/DILATOR
K981527 · QPB
Mentor Corp.
General & Plastic Surgery · 72d
Cleared Jul 09, 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529 · JDS
Smith & Nephew, Inc.
Orthopedic · 71d