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
75097–75120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2002
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND...
K020790 · MOS
Surgi-Vision, Inc.
Radiology · 71d
Cleared May 21, 2002
ULTIMA TENS XL-A1
K020846 · GZJ
Tenscare, Ltd.
Neurology · 67d
Cleared May 21, 2002
ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)
K020993 · MOS
Magna-Lab, Inc.
Radiology · 55d
Cleared May 21, 2002
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
K021262 · MOS
Usa Instruments, Inc.
Radiology · 29d
Cleared May 21, 2002
SIB CATHETER, MODEL 61-7005
K021272 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 29d
Cleared May 21, 2002
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K021310 · JDI
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared May 21, 2002
DEXACARE G4
K021331 · KGI
Osteometer Meditech, Inc.
Radiology · 25d
Cleared May 21, 2002
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
K021479 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 13d
Cleared May 21, 2002
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
K021522 · DZL
Walter Lorenz Surgical, Inc.
Dental · 11d
Cleared May 21, 2002
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS...
K021530 · FPA
Sterling Medivations, Inc.
General Hospital · 11d
Cleared May 20, 2002
GALILEO CAS/NAV TKR SYSTEM
K020298 · HAW
Plus Orthopedics
Neurology · 112d
Cleared May 20, 2002
AGILITY ANKLE REVISION PROSTHESIS
K020541 · HSN
Depuy, Inc.
Orthopedic · 90d
Cleared May 20, 2002
TISSUELINK BIPOLAR FLOATING BALL DEVICE
K020574 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 88d
Cleared May 20, 2002
SYNTHES PILON PLATE
K020602 · HRS
Synthes
Orthopedic · 87d
Cleared May 20, 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · GWM
Medex, Inc.
Neurology · 70d
Cleared May 20, 2002
APEX 800 LASER SYSTEM, MODEL APEX 800
K020849 · GEX
Iridex Corp
General & Plastic Surgery · 66d
Cleared May 20, 2002
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE,...
K020867 · KNW
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 63d
Cleared May 20, 2002
SERRALESTER
K020902 · GAT
Serral, S.A. DE C.V.
General & Plastic Surgery · 61d
Cleared May 20, 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · MQP
Implex Corp.
Orthopedic · 52d
Cleared May 20, 2002
ISOSEEDS I-125
K021343 · KXK
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 21d
Cleared May 17, 2002
INFANT PLETHYSMOGRAPH, MODEL 004400
K011344 · BZC
Collins Medical, Inc.
Anesthesiology · 380d
Cleared May 17, 2002
CARBON POST
K012496 · ELR
J. Morita USA, Inc.
Dental · 287d
Cleared May 17, 2002
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES
K020113 · EBF
Vector Research & Development
Dental · 126d
Cleared May 17, 2002
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · FLE
STERIS Corporation
General Hospital · 71d