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
75553–75576 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2002
TSRH SPINAL SYSTEM
K020699 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 88d
Cleared May 28, 2002
PADPRO, MODEL 2502
K020743 · MKJ
Padpro, LLC
Cardiovascular · 83d
Cleared May 28, 2002
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
K020778 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 78d
Cleared May 28, 2002
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K020893 · LRK
Dennis R. Bailey, Dds
Dental · 70d
Cleared May 28, 2002
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744,...
K021118 · GXZ
Class A Ent.
Neurology · 50d
Cleared May 28, 2002
AROMACRYL
K021121 · EBI
Aromacryl, LLC
Dental · 50d
Cleared May 28, 2002
OSS LES PROXIMAL FEMORAL COMPONENT
K021380 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared May 24, 2002
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
K020315 · MSD
Medcomp
Gastroenterology & Urology · 115d
Cleared May 24, 2002
IRRIGATING CANNULA
K020614 · OCX
Ca Guard, Ltd.
Gastroenterology & Urology · 88d
Cleared May 24, 2002
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
K020628 · HHK
Bioteque America, Inc.
Obstetrics & Gynecology · 87d
Cleared May 24, 2002
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS...
K020642 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 86d
Cleared May 24, 2002
UNITY IS PATIENT VIEWER
K020661 · MSX
General Electric Medical Systems...
Cardiovascular · 84d
Cleared May 24, 2002
SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K020701 · NHW
Guidant Corporation, Cardiac Surgery
Cardiovascular · 81d
Cleared May 24, 2002
SPECTRAL'S 2 IN 1 (TNI-MYO)
K020950 · MMI
Spectral Diagnostics, Inc.
Chemistry · 60d
Cleared May 24, 2002
G4 SLEEVED NAIL
K020962 · HSB
Biomet Manufacturing, Inc.
Orthopedic · 60d
Cleared May 24, 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K021344 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 25d
Cleared May 24, 2002
AT HOME OVULATION TEST, MODEL 9032
K021409 · CEP
Phamatech, Inc.
Chemistry · 21d
Cleared May 24, 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
K021498 · JJT
Bio-Rad
Chemistry · 15d
Cleared May 23, 2002
QUICKCLOT
K013390 · QSY
On Site Gas Systems, Inc.
General & Plastic Surgery · 220d
Cleared May 23, 2002
APATIGHT HA-BONE GRAFT SUBSTITUTE
K013960 · MQV
Cerabio, LLC
Orthopedic · 171d
Cleared May 23, 2002
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET,...
K014192 · MVO
Princeton BioMeditech Corp.
Toxicology · 153d
Cleared May 23, 2002
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · LDJ
Princeton BioMeditech Corp.
Toxicology · 153d
Cleared May 23, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020321 · LON
Becton, Dickinson & CO
Microbiology · 128d
Cleared May 23, 2002
STATUS HCG SERUM/URINE
K020439 · JHI
Princeton BioMeditech Corp.
Chemistry · 101d