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
69481–69504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2004
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K040068 · FMZ
Ohmeda Medical
General Hospital · 93d
Cleared Apr 16, 2004
MICROVASCULAR ANASTOMOTIC DEVICE
K040163 · MVR
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 81d
Cleared Apr 16, 2004
REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K040261 · KWQ
Stryker Spine
Orthopedic · 72d
Cleared Apr 16, 2004
EBI ESL SPINE SPACER SYSTEM
K040482 · MQP
Ebi, L.P.
Orthopedic · 51d
Cleared Apr 16, 2004
FREEDOM HP
K040622 · IOR
Freedom Designs, Inc.
Physical Medicine · 38d
Cleared Apr 16, 2004
PACKAGING TRAY AND COMPONENTS
K040707 · FRG
Vygon Us, LLC
General Hospital · 29d
Cleared Apr 16, 2004
INSTRUMED LAPAROSCOPE AND ACCESSORIES
K040855 · GEI
Instrumed International, Inc.
General & Plastic Surgery · 14d
Cleared Apr 15, 2004
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K023916 · GZJ
Bio-Medical Research, Ltd.
Neurology · 507d
Cleared Apr 15, 2004
RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
K033183 · GEX
Curelight, Ltd.
General & Plastic Surgery · 197d
Cleared Apr 15, 2004
EP DEFLECTABLE CATHETERS
K033963 · DRF
Ep Medsystems, Inc.
Cardiovascular · 115d
Cleared Apr 15, 2004
PIGGYBACK IRRIGATING SYSTEM
K040094 · LJH
Kosin Technologies, LLC
Gastroenterology & Urology · 90d
Cleared Apr 15, 2004
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
K040186 · HBB
The Anspach Effort, Inc.
Neurology · 79d
Cleared Apr 15, 2004
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
K040215 · FAJ
Vision-Sciences, Inc.
Gastroenterology & Urology · 76d
Cleared Apr 15, 2004
AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T
K040528 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 45d
Cleared Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · NBW
Abbott Laboratories
Chemistry · 16d
Cleared Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
K040872 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 13d
Cleared Apr 14, 2004
CARDIOVIT AT-102
K031557 · DPS
Schiller AG
Cardiovascular · 331d
Cleared Apr 14, 2004
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
K033186 · CAE
King Systems Corp.
Anesthesiology · 196d
Cleared Apr 14, 2004
ALTIUS OCT SYSTEM
K033961 · KWP
Interpore Cross Intl.
Orthopedic · 114d
Cleared Apr 14, 2004
MAYO CLINIC BC-10 3.0T
K040122 · MOS
Mayo Clinic
Radiology · 85d
Cleared Apr 14, 2004
SYNTHES MANDIBLE EXTERNAL FIXATOR
K040169 · MQN
Synthes (Usa)
Dental · 79d
Cleared Apr 14, 2004
INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
K040188 · NHP
Draeger Medical Systems, Inc.
Anesthesiology · 77d
Cleared Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · HWC
Smith & Nephew, Inc.
Orthopedic · 63d
Cleared Apr 14, 2004
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND...
K040415 · DXZ
Synovis Surgical Innovations
Cardiovascular · 56d