FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80521–80544 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 27, 2000
THE O'NEIL STERILE FIELD URINARY CATHETER KIT
K002803 · FCM
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 110d
Cleared Dec 27, 2000
PELVIC MUSCLE THERAPY
K002830 · HIR
Colonial Medical Supply
Gastroenterology & Urology · 107d
Cleared Dec 27, 2000
COMPUMEDICS SIESTA SYSTEM
K003175 · OLV
Compumedics Limited
Neurology · 78d
Cleared Dec 27, 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 75d
Cleared Dec 27, 2000
V SCORE WITH AUTO GATE MODEL TBD
K003230 · JAK
Vital Images, Inc.
Radiology · 72d
Cleared Dec 27, 2000
GYROSCAN INTERA 3.0T
K003516 · LNH
Philips Medical Systems North...
Radiology · 43d
Cleared Dec 27, 2000
XISCAN 6000 IMAGING SYSTEM
K003568 · OXO
Xitec, Inc.
Radiology · 37d
Cleared Dec 27, 2000
NUMED Z-MED PTV CATHERERS
K003643 · DQY
NuMED, Inc.
Cardiovascular · 30d