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
66313–66336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2005
CORDIS AMIIA .014 PTA BALLOON CATHETER
K050645 · LIT
Cordis Corp.
Cardiovascular · 18d
Cleared Apr 01, 2005
ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
K050671 · GEI
Surgrx, Inc.
General & Plastic Surgery · 17d
Cleared Apr 01, 2005
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010
K050701 · IYE
Bionix Development Corp.
Radiology · 14d
Cleared Mar 31, 2005
GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR
K043352 · DXN
Gocanning Technology , Ltd.
Cardiovascular · 115d
Cleared Mar 31, 2005
FRESENIUS LIBERTY CYCLER
K043363 · FKX
Fresenius Medical Care North America
Gastroenterology & Urology · 114d
Cleared Mar 31, 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K043418 · FED
Cook Urological, Inc.
Gastroenterology & Urology · 108d
Cleared Mar 31, 2005
FLEXIBLE SPINAL NEEDLE
K043467 · BSP
Epimed International, Inc.
Anesthesiology · 106d
Cleared Mar 31, 2005
GRAFTSAVER
K043515 · GBX
Vescare, Inc.
General & Plastic Surgery · 101d
Cleared Mar 31, 2005
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
K043594 · NLM
Vanguard Medical Concepts, Inc.
Gastroenterology & Urology · 92d
Cleared Mar 31, 2005
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
K050047 · GEX
Cutera, Inc.
General & Plastic Surgery · 80d
Cleared Mar 31, 2005
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
K050172 · DRN
Cardiomedics, Inc.
Cardiovascular · 64d
Cleared Mar 31, 2005
COOK IRELAND SONNET POLYPECTOMY SNARE
K050294 · FDI
Cook Ireland, Ltd.
Gastroenterology & Urology · 52d
Cleared Mar 31, 2005
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K050319 · HBL
Integra Lifesciences Corp.
Neurology · 50d
Cleared Mar 31, 2005
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF &...
K050491 · DXN
Health & Life Co., Ltd.
Cardiovascular · 34d
Cleared Mar 31, 2005
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
K050639 · GCJ
Lumenis, Inc.
Obstetrics & Gynecology · 17d
Cleared Mar 31, 2005
CUTERA SOLERA OPUS AESTHETIC PRODUCT
K050679 · GEX
Cutera, Inc.
General & Plastic Surgery · 15d
Cleared Mar 31, 2005
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
K050730 · DYW
Ultradent Products, Inc.
Dental · 10d
Cleared Mar 31, 2005
NEOTHERMIA EN-BLOC BIOPSY SYSTEM
K050737 · GEI
Neothermia Corporation
General & Plastic Surgery · 10d
Cleared Mar 30, 2005
MOONCUP, STYLE A & B
K040335 · HHE
Mooncup, LLC
Obstetrics & Gynecology · 413d
Cleared Mar 30, 2005
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
K043204 · FRN
Sgarlato Laboratories, Inc.
General Hospital · 132d
Cleared Mar 30, 2005
MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR
K050040 · DXN
Mars Medical Products
Cardiovascular · 82d
Cleared Mar 30, 2005
NOVOFINE AUTOCOVER 30G X 8MM
K050106 · FMI
Novo Nordisk, Inc.
General Hospital · 71d
Cleared Mar 30, 2005
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM...
K050217 · MTD
Biosense Webster, Inc.
Cardiovascular · 58d
Cleared Mar 30, 2005
HEMOSIL SILICA CLOTTING TIME
K050221 · GFO
Instrumentation Laboratory CO
Hematology · 58d