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

Filters: Cleared only ×
176,076 results
58345–58368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2007
HDC STERILE SPIDER SCREW
K071851 · DZE
Hdc S.R.L.
Dental · 105d
Cleared Oct 18, 2007
PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R
K071909 · KOC
Barkey GmbH & Co. KG
Gastroenterology & Urology · 99d
Cleared Oct 18, 2007
AEQUALIS REVERSED ADAPTER
K071948 · PHX
Tornier
Orthopedic · 97d
Cleared Oct 18, 2007
COPD LIQUID OXYGEN PORTABLE, MODEL 300P
K072011 · BYJ
Copd Partners, Inc.
Anesthesiology · 87d
Cleared Oct 18, 2007
RESTORATION ADM SYSTEM
K072020 · MEH
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Oct 18, 2007
PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS
K072050 · BSO
Life-Tech, Inc.
Anesthesiology · 84d
Cleared Oct 18, 2007
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
K072125 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 18, 2007
MINRAD INC. NASAL SCAVENGING CIRCUIT
K072255 · CBN
Minrad, Inc.
Anesthesiology · 66d
Cleared Oct 18, 2007
SYNOSS SYNTHETIC BONE GRAFT MATERIAL
K072397 · LYC
Collagen Matrix, Inc.
Dental · 52d
Cleared Oct 18, 2007
MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR
K072516 · MWI
Midmark Diagnostics Group
Cardiovascular · 41d
Cleared Oct 18, 2007
ALPHARD CONE BEAM CT, MODEL X178
K072574 · JAK
Takara Belmont Corp.
Radiology · 35d
Cleared Oct 18, 2007
PULSION PICCO-2, MODEL 8500
K072735 · DXG
Pulsion Medical Systems AG
Cardiovascular · 21d
Cleared Oct 17, 2007
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
K063145 · DIP
Thermo Electron OY
Toxicology · 366d
Cleared Oct 17, 2007
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
K070405 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 247d
Cleared Oct 17, 2007
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
K070438 · MRZ
Medtronic Minimed, Inc.
General Hospital · 244d
Cleared Oct 17, 2007
T-PORT HP INFUSION PORT
K071993 · LJT
Pfm Medical, Inc.
General Hospital · 89d
Cleared Oct 17, 2007
EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM
K072046 · IYE
Brainlab AG
Radiology · 84d
Cleared Oct 17, 2007
SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K072365 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 55d
Cleared Oct 17, 2007
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1...
K072435 · JIX
Dade Behring, Inc.
Chemistry · 48d
Cleared Oct 17, 2007
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E...
K072797 · IYO
General Electric Co.
Radiology · 16d
Cleared Oct 16, 2007
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
K071049 · EZL
Tyco Healthcare
Gastroenterology & Urology · 186d
Cleared Oct 16, 2007
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
K071087 · FRG
STERIS Corporation
General Hospital · 182d
Cleared Oct 16, 2007
SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50,...
K071382 · FOZ
Shinchang Medical Co., Ltd.
General Hospital · 152d
Cleared Oct 16, 2007
LIGHT SABRE SPINAL ACCESS DEVICE
K071814 · KNW
Minrad, Inc.
Gastroenterology & Urology · 106d