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
75265–75288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2002
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
K021287 · DTN
Medtronic Perfusion Systems
Cardiovascular · 14d
Cleared May 07, 2002
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
K021325 · MHX
General Electric Medical Systems...
Cardiovascular · 11d
Cleared May 07, 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K021347 · MWI
Philips Medical Systems
Cardiovascular · 8d
Cleared May 06, 2002
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K011690 · JAQ
Proxima Therapeutics, Inc.
Radiology · 340d
Cleared May 06, 2002
PRE-LOADED BIOSTINGER HORNET
K020377 · HWC
Linvatec Corp.
Orthopedic · 90d
Cleared May 06, 2002
PPD BALLOON DILATATION CATHETER
K020379 · KNT
Telemed Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 06, 2002
EXPANDABLE KNEE
K020381 · KRO
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared May 06, 2002
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
K020383 · JWH
Ortho Development Corp.
Orthopedic · 90d
Cleared May 06, 2002
T2 ARTHRODESIS NAIL SYSTEM
K020384 · HSB
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared May 06, 2002
SPIFE 2000/3000 ALP 40, 20
K020625 · CIN
Helena Laboratories
Chemistry · 69d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
K020627 · LTT
Dade Microscan, Inc.
Microbiology · 69d
Cleared May 06, 2002
INRATIO
K020679 · GJS
Hemosense, Inc.
Hematology · 63d
Cleared May 06, 2002
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG...
K020716 · DJG
Rapid Diagnostics, Inc.
Toxicology · 62d
Cleared May 06, 2002
WET CHAMBER
K020781 · NAD
Kinetic Concepts, Inc.
General & Plastic Surgery · 56d
Cleared May 06, 2002
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K020917 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 46d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
K020937 · JWY
Dade Microscan, Inc.
Microbiology · 45d
Cleared May 06, 2002
MICROSTREP PLUS PANEL WITH AMPICILLIN
K021037 · JWY
Dade Behring, Inc.
Microbiology · 35d
Cleared May 03, 2002
PSYCHEMEDICS RIA CANNABINOID ASSAY
K011426 · LAT
Psychemedics Corp.
Toxicology · 360d
Cleared May 03, 2002
INDWELLING FECAL MANAGEMENT SYSTEM
K012113 · KNT
Bowel Management Systems, LLC
Gastroenterology & Urology · 301d
Cleared May 03, 2002
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
K012800 · HRY
Whiteside Biomechanics, Inc.
Orthopedic · 255d
Cleared May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 144d
Cleared May 03, 2002
SANIDAD HEALTH-UP TENS MP-73725
K014126 · GZJ
Roc Chinese-European Industrial...
Neurology · 137d
Cleared May 03, 2002
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230...
K020354 · GXD
Baylis Medical Co., Inc.
Neurology · 88d
Cleared May 03, 2002
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
K020365 · KRI
3t Medical Systems, LLC
Cardiovascular · 88d