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
75769–75792 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2002
Q-STRESS ECHO BED
K021171 · DPS
Medical Positioning, Inc.
Cardiovascular · 26d
Cleared May 08, 2002
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
K021300 · DSI
Philips Medical Systems
Cardiovascular · 14d
Cleared May 08, 2002
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
K021410 · ELW
Dentsply Intl.
Dental · 5d
Cleared May 07, 2002
STEAM STERILIZATION INTERGRATOR
K012195 · JOJ
Dana Products, Inc.
General Hospital · 298d
Cleared May 07, 2002
MAINSTREAM WATER PURIFICATION DEVICE
K012716 · NHV
Prismedical Corp.
Gastroenterology & Urology · 265d
Cleared May 07, 2002
HIGH SILVER CONVENTIONAL
K020452 · EJJ
Ab Ardent
Dental · 85d
Cleared May 07, 2002
SULTAN SPOROX TEST VIAL, MODEL 75195
K020612 · JOJ
Sultan Chemists, Inc.
General Hospital · 71d
Cleared May 07, 2002
OSSIFORM
K020720 · LYC
Unicare Biomedical, Inc.
Dental · 63d
Cleared May 07, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
K021251 · DSI
Philips Medical Systems
Cardiovascular · 18d
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