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
81121–81144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2001
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
K003415 · DXQ
Wang & Li, Inc.
Cardiovascular · 62d
Cleared Jan 03, 2001
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER...
K003729 · DYB
St Jude Medical
Cardiovascular · 30d
Cleared Jan 03, 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH...
K003756 · JEY
Bionx Implants, Inc.
Dental · 28d
Cleared Jan 02, 2001
CASTLE MODEL 233HC STEAM STERILIZER
K003441 · FLE
Getinge/Castle, Inc.
General Hospital · 57d
Cleared Jan 02, 2001
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES...
K003451 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 56d
Cleared Jan 02, 2001
FLEXICAST
K003509 · EJH
American Dent-All, Inc.
Dental · 49d
Cleared Jan 02, 2001
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
K003563 · LZA
Ning BO Yujiang Rubber & Plastic Co.
General Hospital · 43d
Cleared Jan 02, 2001
MODIFICATION TO EBI SPINELINK SYSTEM
K003764 · MNH
Ebi, L.P.
Orthopedic · 27d
Cleared Jan 02, 2001
WATER PURIFICATION SYSTEM
K994292 · FIP
Water & Power Technologies, Inc.
Gastroenterology & Urology · 378d
Cleared Dec 29, 2000
INJECTRITE-C15 AND INJECTRITE-C30
K002127 · FMF
Sterling Medivations, Inc.
General Hospital · 168d
Cleared Dec 29, 2000
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182 · FLL
Avita Corporation
General Hospital · 163d
Cleared Dec 29, 2000
BIOMET EXTERNAL WRIST PLATE
K003240 · LXT
Biomet, Inc.
Orthopedic · 73d
Cleared Dec 29, 2000
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS...
K992424 · LJS
Plastimed Laboratoire Pharmaceutique
General Hospital · 527d
Cleared Dec 28, 2000
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
K001576 · NBV
Prosurg, Inc.
Obstetrics & Gynecology · 220d
Cleared Dec 28, 2000
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K003040 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 28, 2000
BRAIN COIL, MODEL 9800GE-64
K003097 · MOS
Midwest Rf, LLC
Radiology · 86d
Cleared Dec 28, 2000
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 76d
Cleared Dec 28, 2000
SPECIAL PROCEDURES HEAD COIL
K003386 · MOS
Midwest Rf, LLC
Radiology · 58d
Cleared Dec 27, 2000
APNOESCREEN PRO, ALPHA SCREEN PRO
K000396 · MNR
Erich Jaeger, Inc.
Anesthesiology · 324d
Cleared Dec 27, 2000
PHORMAX EAGLE SCANNER SYSTEM
K001499 · MQB
Phormax Corp.
Radiology · 226d
Cleared Dec 27, 2000
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · FTM
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 203d
Cleared Dec 27, 2000
SURGISIS PERIPHERAL VASCULAR PATCH
K001785 · DXZ
Cook Biotech, Inc.
Cardiovascular · 197d
Cleared Dec 27, 2000
PHACOFRAGMENTATION SYSTEM MEGATRON
K002031 · HQC
Asclepion-Meditec AG
Ophthalmic · 177d
Cleared Dec 27, 2000
CARTOUCH
K002197 · DPS
Cardionics, Inc.
Cardiovascular · 160d