FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
133417–133440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1988
EXEL 905 SERIES CT SCANNER
K884667 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
EXEL 1002 CT SCANNER
K884668 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
EXEL 2002 & 2002FS CT SCANNER
K884669 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
K885076 · JPA
Organon Teknika Corp.
Hematology · 22d
Cleared Dec 30, 1988
DIOPTICS EYESHIELDS
K885163 · HOY
Dioptics
Ophthalmic · 17d
Cleared Dec 29, 1988
NEURAL MAGNETIC STIMULATOR, THE D190
K883340 · GWF
Tracor Northern, Inc.
Neurology · 142d
Cleared Dec 29, 1988
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
K884035 · JJE
Sclavo, Inc.
Chemistry · 97d
Cleared Dec 29, 1988
MODIFIED CHICK AMBULATORY HALO
K884242 · JEC
Chick Medical Products
Orthopedic · 79d
Cleared Dec 29, 1988
ROGOZINSKI SPINAL SYSTEM
K884263 · KWP
Richards Medical Co., Inc.
Orthopedic · 79d
Cleared Dec 29, 1988
CLENSATRON AUTOMATIC CONTACT LENS CLEANER
K884414 · LYL
Questech Intl., Inc.
Ophthalmic · 70d
Cleared Dec 29, 1988
AE-800PA EEG MODULE
K884537 · GWQ
Nihon Kohden America, Inc.
Neurology · 62d
Cleared Dec 29, 1988
VIRGO(R) MICROWELL ALT ASSAY
K884784 · CKD
Electro-Nucleonics, Inc.
Chemistry · 44d
Cleared Dec 29, 1988
MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
K884888 · JDI
Protek, Inc.
Orthopedic · 37d
Cleared Dec 29, 1988
VISUAL BLOOD GLUCOSE TEST SYSTEM
K884993 · CGA
Diagnostic Systems
Chemistry · 28d
Cleared Dec 29, 1988
BEHRING POLAROID OPUS THEOPHYLLINE
K885044 · KLS
Pb Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Dec 28, 1988
PROCEDURE PACKS CONTRAST MEDIA SETS
K882717 · DTL
Procedure Packs, Inc.
Cardiovascular · 180d
Cleared Dec 28, 1988
EDENTRACE MULTI-CHARTER MODEL 3700
K883315 · DSF
Edentec Corp.
Cardiovascular · 145d
Cleared Dec 28, 1988
LIFEPAK 50 MONITOR/DEFIBRILLATOR
K883617 · LDD
Physio-Control Corp.
Cardiovascular · 126d
Cleared Dec 28, 1988
PERFECTA II TOTAL HIP SYSTEM
K883618 · JDI
Orthomet, Inc.
Orthopedic · 126d
Cleared Dec 28, 1988
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
K884153 · FGB
Candela Laser Corp.
Gastroenterology & Urology · 89d
Cleared Dec 28, 1988
ALLERGAN LENS CASE
K884251 · LRX
Allergan Optical
Ophthalmic · 78d
Cleared Dec 28, 1988
UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID
K884351 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 75d
Cleared Dec 28, 1988
THROMBIN-PREST REAGENT KIT
K884384 · GJA
American Bioproducts Co.
Hematology · 71d
Cleared Dec 28, 1988
FIBRI-PREST/THROMBIN-PREST CONTROLS
K884385 · GJA
American Bioproducts Co.
Hematology · 71d