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
80329–80352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2001
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 &...
K010010 · GEI
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Apr 02, 2001
COUCH FOR TOTAL BODY RADIATION
K010063 · IYE
Arplay Medical S.A.
Radiology · 84d
Cleared Apr 02, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K010092 · GWF
Excel Tech. , Ltd.
Neurology · 81d
Cleared Apr 02, 2001
BIPOLAR COAGULATION SYSTEM
K010112 · GEI
Enable Medical Corp.
General & Plastic Surgery · 80d
Cleared Apr 02, 2001
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
K010192 · GEI
Antyllos Medizintechnik GmbH
General & Plastic Surgery · 70d
Cleared Apr 02, 2001
FLEXIBLE ENDOSCOPIC SCISSORS
K010412 · OCZ
Telemed Systems, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 02, 2001
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM...
K010685 · HSX
Zimmer, Inc.
Orthopedic · 25d
Cleared Apr 02, 2001
PHILIPS BV LIBRA
K010762 · OXO
Philips Medical Systems, Inc.
Radiology · 19d
Cleared Mar 30, 2001
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001398 · DHC
Corgenix, Inc.
Immunology · 331d
Cleared Mar 30, 2001
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE...
K002019 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 270d
Cleared Mar 30, 2001
SARSTEDT NEEDLE PROTECTOR
K003382 · FMI
Sarstedt, Inc.
General Hospital · 150d
Cleared Mar 30, 2001
ELISA TEST, SEROLOGY
K003794 · LYR
Micro Detect, Inc.
Microbiology · 112d
Cleared Mar 30, 2001
SHEER THIN AROMAS RED LATEX CONDOM
K010028 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 86d
Cleared Mar 30, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE...
K010097 · LZA
Shen Wei (Usa), Inc.
General Hospital · 78d
Cleared Mar 30, 2001
PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS...
K010538 · FPA
Rd Medical Mfg., Inc.
General Hospital · 35d
Cleared Mar 30, 2001
GE CT-PET SYSTEM
K010641 · JAK
Ge Medical Systems, Inc.
Radiology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · DKZ
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9083 T
K010646 · MVO
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9073 T
K010650 · DIO
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9133 T
K010651 · LCM
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · JIX
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Mar 30, 2001
POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
K010663 · LYZ
Tong Ruhn Medical Products Co., Ltd.
General Hospital · 24d
Cleared Mar 30, 2001
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
K010721 · IZI
Siemens Medical Corp.
Radiology · 18d
Cleared Mar 30, 2001
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
K994381 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 458d