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
87265–87288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
K984278 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared Dec 11, 1998
AVL OPTI CRITICAL CARE ANALYZER
K984299 · JFP
Avl Scientific Corp.
Chemistry · 10d
Cleared Dec 10, 1998
INTERSOURCE
K973328 · KXK
International Brachytherapy S.A.
Radiology · 462d
Cleared Dec 10, 1998
MEDTRONIC ANGIOGRAPHIC CATHETER
K980973 · DQO
Medtronics Interventional Vascular
Cardiovascular · 269d
Cleared Dec 10, 1998
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC...
K981922 · QPB
Microaire Surgical Instruments, Inc.
General & Plastic Surgery · 192d
Cleared Dec 10, 1998
CLEARVIEW IM
K981946 · KTN
Unipath , Ltd.
Immunology · 190d
Cleared Dec 10, 1998
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
K982076 · CGA
Amira Medical, Inc.
Chemistry · 181d
Cleared Dec 10, 1998
ALOE THERAPY ORAL RINSE
K983182 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 90d
Cleared Dec 10, 1998
GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON,...
K983183 · EFB
Bien Air USA, Inc.
Dental · 90d
Cleared Dec 10, 1998
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
K983187 · KNW
Medsol Corp.
Gastroenterology & Urology · 90d
Cleared Dec 10, 1998
ALGISITE M
K983210 · KMF
Smith & Nephew, Inc.
General & Plastic Surgery · 87d
Cleared Dec 10, 1998
MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T
K983412 · LJS
Medical Components, Inc.
General Hospital · 73d
Cleared Dec 10, 1998
GORE REVOX THYROPLASTY IMPLANT
K983525 · MIX
W.L. Gore & Associates, Inc.
Ear, Nose, Throat · 63d
Cleared Dec 10, 1998
ALUMINA-ZINC OXIDE POWDERS F AND R
K983752 · EMA
Harry J. Bosworth Co.
Dental · 48d
Cleared Dec 10, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN...
K983801 · LSE
Zeus Scientific, Inc.
Microbiology · 43d
Cleared Dec 10, 1998
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
K983833 · KMF
Westaim Biomedical, Inc.
General & Plastic Surgery · 41d
Cleared Dec 10, 1998
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K984099 · JPK
R&D Systems, Inc.
Hematology · 23d
Cleared Dec 10, 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · DDR
Dade Behring, Inc.
Immunology · 17d
Cleared Dec 10, 1998
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
K984379 · CBK
Puritan Bennett Corp.
Anesthesiology · 3d
Cleared Dec 09, 1998
MELODIE INFUSION PUMP
K980378 · FRN
Compagnie DE Developpement Aguettant
General Hospital · 313d
Cleared Dec 09, 1998
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
K981737 · MKJ
Katecho, Inc.
Cardiovascular · 205d
Cleared Dec 09, 1998
STARTRACK INFANT GRAPHICS MONITOR
K983274 · BZK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 83d
Cleared Dec 09, 1998
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND...
K983303 · MGP
Innovative Technologies , Ltd.
General & Plastic Surgery · 79d
Cleared Dec 09, 1998
BATCH #6060 CONDUCTIVE GEL
K983964 · GYB
Skylark Device Co., Ltd.
Neurology · 33d