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
75889–75912 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2002
SERRALSILK
K020901 · GAP
Serral, S.A. DE C.V.
General & Plastic Surgery · 37d
Cleared Apr 26, 2002
SUPER EON PLUS FEMORAL STEMS
K020989 · JDI
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Apr 26, 2002
ACIST PLUS 4 ANGIOGRAPHIC CATHETER
K021015 · DQO
Acist Medical Systems
Cardiovascular · 28d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123 · MDB
bioMerieux, Inc.
Microbiology · 18d
Cleared Apr 26, 2002
SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
K021197 · FMF
Hosuk Co., Ltd.
General Hospital · 10d
Cleared Apr 25, 2002
COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
K010128 · DYB
Cook Vascular, Inc.
Cardiovascular · 464d
Cleared Apr 25, 2002
PVS BASIC 2
K013310 · HQD
Paragon Vision Sciences
Ophthalmic · 203d
Cleared Apr 25, 2002
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
K013517 · DQY
Medtronic Vascular
Cardiovascular · 185d
Cleared Apr 25, 2002
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
K014089 · DIS
Sun Biomedical Laboratories, Inc.
Toxicology · 135d
Cleared Apr 25, 2002
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING...
K014168 · IYN
Biosound Esaote, Inc.
Radiology · 127d
Cleared Apr 25, 2002
ISAAC 1.5 T MR SYSTEM
K020268 · LNH
Chi, Inc.
Radiology · 90d
Cleared Apr 25, 2002
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
K020333 · DXT
Atrion Medical Products, Inc.
Cardiovascular · 84d
Cleared Apr 25, 2002
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
K020708 · DPS
Philips Medical Systems, Inc.
Cardiovascular · 51d
Cleared Apr 25, 2002
SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF...
K021005 · FPA
Sterling Medivations, Inc.
General Hospital · 28d
Cleared Apr 25, 2002
S2 FEMORAL NAIL
K021026 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 25, 2002
S2 TIBIAL NAIL
K021027 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 24, 2002
LYMPHA VISION-EXPERT
K003896 · GXY
Bexley Trading, Inc.
Neurology · 492d
Cleared Apr 24, 2002
DATASCOPE'S 8FR. ALT B IAB
K020257 · DSP
Datascope Corp.
Cardiovascular · 90d
Cleared Apr 24, 2002
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
K020289 · LNH
Machnet BV
Radiology · 86d
Cleared Apr 24, 2002
AGC SPEZIALLEGIERUNG
K020347 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 79d
Cleared Apr 24, 2002
JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
K020515 · DWF
Jostra AG
Cardiovascular · 68d
Cleared Apr 24, 2002
POLYMEDCO HBA1C TEST
K020532 · LCP
Polymedco, Inc.
Hematology · 64d
Cleared Apr 24, 2002
SIMPLICITY
K020570 · KLE
Apex Dental Materials, Inc.
Dental · 62d
Cleared Apr 24, 2002
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
K020601 · MOS
Odin Medical Technologies , Ltd.
Radiology · 61d