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
78481–78504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2001
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
K012710 · LYZ
Shijiazhuang Brilliance Plastic Co.,...
General Hospital · 51d
Cleared Oct 04, 2001
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · GAT
Arthrex, Inc.
General & Plastic Surgery · 34d
Cleared Oct 04, 2001
URETEX SUP PUBOURETHRAL SLING
K012949 · OTN
Sofradim Production
Gastroenterology & Urology · 30d
Cleared Oct 04, 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · DXT
Medrad, Inc.
Cardiovascular · 30d
Cleared Oct 04, 2001
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING...
K012967 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 04, 2001
MODIFICATION TO: THERMACOOL IIA
K013034 · GEI
Thermage, Inc.
General & Plastic Surgery · 24d
Cleared Oct 03, 2001
MEDCOMP EXCELL SPLIT TIP CATHETER
K010306 · MSD
Medcomp
Gastroenterology & Urology · 244d
Cleared Oct 03, 2001
PRO-FEMUR
K012091 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Oct 03, 2001
THE SALICEPT ORAL PATCH
K012126 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 89d
Cleared Oct 03, 2001
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
K012336 · DSI
Medical Data Electronics
Cardiovascular · 71d
Cleared Oct 03, 2001
NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
K012345 · IPL
Bromac Assistive Technology
Physical Medicine · 71d
Cleared Oct 03, 2001
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
K012446 · BSZ
Charles A. Smith
Anesthesiology · 63d
Cleared Oct 03, 2001
ATAC PAK CPK REAGENT KIT
K012474 · CGS
Elan Holdings, Inc.
Chemistry · 62d
Cleared Oct 03, 2001
EASYTRAVEL
K012592 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 54d
Cleared Oct 03, 2001
MODIFICATION TO VAXCEL DIALYSIS CATHETER
K012948 · MSD
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 29d
Cleared Oct 03, 2001
BIPOLAR IRRIGATION FORCEPS
K012986 · GEI
Aesculap, Inc.
General & Plastic Surgery · 27d
Cleared Oct 03, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS...
K012992 · DQA
Masimo Corp.
Anesthesiology · 27d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
K012999 · DIF
Biosite Incorporated
Toxicology · 27d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
K013002 · DIF
Biosite Incorporated
Toxicology · 27d
Cleared Oct 03, 2001
BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2
K013009 · EBF
Sybron Dental Specialties, Inc.
Dental · 27d
Cleared Oct 03, 2001
MODIFICATION TO FLOUROLAB PLUS
K013025 · HAW
Z-Kat, Inc.
Neurology · 23d
Cleared Oct 03, 2001
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
K994105 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 667d
Cleared Oct 02, 2001
GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE),...
K012383 · FRN
Alaris Medical Systems, Inc.
General Hospital · 67d