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
72721–72744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · DPW
Terumo Cardiovascular Systems Corp.
Cardiovascular · 84d
Cleared May 14, 2003
DEPILASE TWIN YAG LASER SYSTEM
K030510 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 84d
Cleared May 14, 2003
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
K030512 · GCJ
Guidant Corp.
General & Plastic Surgery · 84d
Cleared May 14, 2003
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K030549 · DQX
Guidcorp
Cardiovascular · 82d
Cleared May 14, 2003
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT,...
K030748 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 65d
Cleared May 14, 2003
GEM
K030917 · BZG
Collins Medical, Inc.
Anesthesiology · 51d
Cleared May 14, 2003
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
K031086 · GWM
Integra Neurosciences
Neurology · 37d
Cleared May 14, 2003
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
K031123 · HCA
Codman & Shurtleff, Inc.
Neurology · 35d
Cleared May 14, 2003
OLYMPIC CFM 6000
K031149 · OMA
Olympic Medical Corp.
Neurology · 34d
Cleared May 14, 2003
MATRIX STRETCH RESISTANT DETACHABLE COIL
K031168 · HCG
Boston Scientific, Target
Neurology · 30d
Cleared May 14, 2003
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS...
K031277 · DQX
Jomed, Inc.
Cardiovascular · 22d
Cleared May 14, 2003
IBC FLOPUMP WITH GBS COATING
K031300 · KFM
Gish Biomedical, Inc.
Cardiovascular · 20d
Cleared May 13, 2003
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
K022834 · MHX
Ge Medical Systems Information...
Cardiovascular · 260d
Cleared May 13, 2003
INBODY AP1 BODY COMPOSITION ANALYZER
K023478 · MNW
Biospace Co.,Ltd
Gastroenterology & Urology · 209d
Cleared May 13, 2003
SYREX PRE-FILLED SYRINGE
K023740 · NZW
Excelsior Medical Corp.
General Hospital · 187d
Cleared May 13, 2003
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
K030209 · MPB
The Kendall Company
Gastroenterology & Urology · 112d
Cleared May 13, 2003
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
K031037 · DWF
Medtronic Perfusion Systems
Cardiovascular · 42d
Cleared May 13, 2003
MODIFICATION TO EASYS TRANSVERSE CONNECTION
K031290 · MNH
Scient'X USA, Inc.
Orthopedic · 20d
Cleared May 13, 2003
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
K031333 · IZI
Philips Medical Systems North...
Radiology · 15d
Cleared May 13, 2003
ADVANTAGE WORKSTATION PASTING 1.1
K031396 · LNH
GE Medical Systems
Radiology · 11d
Cleared May 12, 2003
COOLTOUCH ND: YAG LASER SYSTEM
K030453 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 90d
Cleared May 12, 2003
CELL-DYN 1800 SYSTEM
K030513 · GKZ
Abbott Laboratories
Hematology · 82d
Cleared May 12, 2003
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
K030775 · LKJ
Immuno Concepts, N.A. , Ltd.
Immunology · 62d
Cleared May 12, 2003
RANDOX AMMONIA
K030873 · JIF
Randox Laboratories, Ltd.
Chemistry · 53d