Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
72361–72384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2003
UF BRACHYTHERAPY STAND
K023430 · IYO
University of Florida
Radiology · 256d
Cleared Jun 24, 2003
BD VIPER INSTRUMENT
K023955 · JQW
Becton, Dickinson & CO
Microbiology · 209d
Cleared Jun 24, 2003
CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM...
K024270 · CAH
Intersurgical, Inc.
General Hospital · 183d
Cleared Jun 24, 2003
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
K030578 · NAY
Computer Motion, Inc.
General & Plastic Surgery · 120d
Cleared Jun 24, 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 96d
Cleared Jun 24, 2003
ECLIPSE
K030981 · LNH
Varian Medical Systems, Inc.
Radiology · 88d
Cleared Jun 24, 2003
MODIFICATION TO TRANSPORT INCUBATOR 185
K031096 · FPL
International Biomedics, Inc.
General Hospital · 78d
Cleared Jun 24, 2003
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K031154 · JDW
Sintea Biotech, Inc.
Orthopedic · 74d
Cleared Jun 24, 2003
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · FMI
Becton, Dickinson & CO
General Hospital · 69d
Cleared Jun 24, 2003
SYNVITRO HYADASE
K031228 · MQL
Medicult A/S
Obstetrics & Gynecology · 67d
Cleared Jun 24, 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
K031393 · NIG
Bayer Healthcare, LLC
Immunology · 53d
Cleared Jun 24, 2003
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
K031460 · BZD
Respironics, Inc.
Anesthesiology · 47d
Cleared Jun 24, 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572 · LPH
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 24, 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595 · KWP
U&I Corp., America
Orthopedic · 34d
Cleared Jun 24, 2003
SPECTRAPULSE
K031680 · GEX
Primary Technology, LLC
General & Plastic Surgery · 25d
Cleared Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725 · KTT
Synthes (Usa)
Orthopedic · 21d
Cleared Jun 24, 2003
ENDO GATOR SYSTEM
K031773 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 24, 2003
NITREX NITINOL GUIDEWIRE
K031864 · DQX
Ev3 Corporation
Cardiovascular · 8d
Cleared Jun 23, 2003
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED...
K023333 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 259d
Cleared Jun 23, 2003
PER, MODEL MEMO
K030218 · DXH
Medical Monitors Pty., Ltd.
Cardiovascular · 153d
Cleared Jun 23, 2003
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
K030935 · HHI
Acmi Corporation
Obstetrics & Gynecology · 90d
Cleared Jun 23, 2003
EMBRYOGLUE
K031015 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 84d
Cleared Jun 23, 2003
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K031038 · NBC
Bayer Healthcare, LLC
Chemistry · 83d
Cleared Jun 23, 2003
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
K031065 · MEG
Syringex Medical, Inc.
General Hospital · 81d