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

Filters: Cleared only ×
176,076 results
61753–61776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2006
CYL-FIL OXYGEN SYSTEM
K061785 · CAN
Responsive Respiratory, Inc.
Anesthesiology · 76d
Cleared Sep 07, 2006
AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM
K062048 · GEX
Aesthera Corporation
General & Plastic Surgery · 49d
Cleared Sep 06, 2006
SYNTHES OC FUSION SYSTEM
K053418 · KWP
Synthes Spine Co.Lp
Orthopedic · 272d
Cleared Sep 06, 2006
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES...
K053540 · GEX
Intermedic Arfran, SA
General & Plastic Surgery · 260d
Cleared Sep 06, 2006
BIOSET XC
K060180 · MBP
Regeneration Technologies, Inc.
Orthopedic · 226d
Cleared Sep 06, 2006
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
K060623 · FER
Cook Ireland, Ltd.
Gastroenterology & Urology · 182d
Cleared Sep 06, 2006
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT...
K060765 · LFR
Hemocue AB
Chemistry · 169d
Cleared Sep 06, 2006
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K061394 · BSP
Busse Hospital Disposables, Inc.
Anesthesiology · 110d
Cleared Sep 06, 2006
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR...
K061663 · EOB
Rtc Inc.-Memcath Technologies, LLC
Ear, Nose, Throat · 93d
Cleared Sep 06, 2006
MEDGRAPHICS ULTIMA SYSTEM
K061731 · BZL
Medical Graphics Corp.
Anesthesiology · 78d
Cleared Sep 06, 2006
URYXXON RELAX URINE ANALYZER
K061742 · JIL
Macherey-Nagel GmbH & Co. KG
Chemistry · 78d
Cleared Sep 06, 2006
MEDIBYTE, MODEL MP8
K061764 · MNR
Braebon Medical Corp.
Anesthesiology · 76d
Cleared Sep 06, 2006
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL...
K061825 · DCN
Dade Behring, Inc.
Chemistry · 70d
Cleared Sep 06, 2006
BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120
K061884 · GEI
Bovie Medical
General & Plastic Surgery · 65d
Cleared Sep 06, 2006
ART LAB SOFTWARE
K061961 · LLZ
Pie Medical
Radiology · 57d
Cleared Sep 06, 2006
XCELERA
K061995 · LLZ
Philips Medical Systems North America...
Radiology · 54d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
K062034 · JIX
Dade Behring, Inc.
Chemistry · 49d
Cleared Sep 06, 2006
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
K062042 · LIL
Plethora Solutions
Gastroenterology & Urology · 49d
Cleared Sep 06, 2006
AIE REGION OF INTEREST IMAGE ENHANCEMENT
K062059 · LLZ
Advanced Image Enhancement
Radiology · 48d
Cleared Sep 06, 2006
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
K062067 · LZA
Shen Wei (Usa), Inc.
General Hospital · 47d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
K062199 · DLJ
Dade Behring, Inc.
Toxicology · 36d
Cleared Sep 06, 2006
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · JIF
Dade Behring, Inc.
Chemistry · 28d
Cleared Sep 06, 2006
PHILIPS MP5 INTELLIVUE PATIENT MONITOR
K062392 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 21d
Cleared Sep 06, 2006
GATEWAY THORACOLUMBAR PLATE SYSTEM
K062407 · KWQ
Globus Medical, Inc.
Orthopedic · 20d