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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
53257–53280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2009
ZELTIQ SYSTEM
K090094 · GEX
Zeltiq Aesthetics
General & Plastic Surgery · 126d
Cleared May 20, 2009
SUPRATHEL WOUND AND BURN DRESSING
K090160 · QSZ
Polymedics Innovations, GmbH
General & Plastic Surgery · 118d
Cleared May 20, 2009
BABI*PLUS BUBBLE PAP VALVE
K090317 · BYE
A Plus Medical
Anesthesiology · 100d
Cleared May 20, 2009
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 97d
Cleared May 20, 2009
HINGE PEDIATRIC PLATING SYSTEM
K090440 · HRS
Pega Medical, Inc.
Orthopedic · 89d
Cleared May 20, 2009
SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01
K090530 · MBI
Ross Creek Medical, Inc.
Orthopedic · 82d
Cleared May 20, 2009
OCULUS MICROCYN WOUND GEL
K090725 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 62d
Cleared May 20, 2009
POWER INFUSER, MODEL M100B-3A
K090736 · FRN
ZOLL Medical Corporation
General Hospital · 62d
Cleared May 20, 2009
APLION TOPICAL CARE SYSTEM
K091133 · NAD
Aplion Medical,Llc
General & Plastic Surgery · 30d
Cleared May 20, 2009
SYNGO TRUED
K091373 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared May 19, 2009
BRANEMARK INTEGRATION BIOHELIX IMPLANTS
K090005 · DZE
Branemark Integration AB
Dental · 137d
Cleared May 19, 2009
EG-3670URK
K090196 · ODG
Pentax Medical Company
Radiology · 112d
Cleared May 19, 2009
EG-3870UTK
K090197 · ODG
Pentax Medical Company
Radiology · 112d
Cleared May 19, 2009
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
K090425 · MAX
Alphatec Spine, Inc.
Orthopedic · 89d
Cleared May 19, 2009
BONGROS HA
K090793 · LYC
Bioalpha, Inc.
Dental · 56d
Cleared May 19, 2009
DEPUY SPINE LATERAL SYSTEM
K090899 · MAX
Depuy Spine, Inc.
Orthopedic · 48d
Cleared May 19, 2009
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
K091070 · FFX
Sierra Scientific Instruments, Inc.
Gastroenterology & Urology · 35d
Cleared May 18, 2009
MASTERSCREEN PAED - BABY BODY
K081823 · CCM
Viasys Healthcare GmbH
Anesthesiology · 325d
Cleared May 18, 2009
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
K083327 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 187d
Cleared May 18, 2009
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
K083455 · MUU
Medi-Khan USA, Inc.
General & Plastic Surgery · 178d
Cleared May 18, 2009
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
K083507 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 173d
Cleared May 18, 2009
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
K090062 · MQB
Direct Digital Imaging Technology...
Radiology · 129d
Cleared May 18, 2009
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)
K090520 · LYZ
Shandong Huayue Glove Co., Ltd.
General Hospital · 81d
Cleared May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672 · MQB
Agfa Healthcare N.V.
Radiology · 66d