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
81577–81600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2000
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · GEH
Endocare, Inc.
General & Plastic Surgery · 83d
Cleared Nov 13, 2000
NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
K002677 · BXM
Nuvasive, Inc.
Anesthesiology · 77d
Cleared Nov 13, 2000
TISSUELINK MONOPOLAR FLOATING BALL'
K002680 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 77d
Cleared Nov 13, 2000
ALLON 2001 MODIFIED
K003349 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 18d
Cleared Nov 09, 2000
SAMSUNG 10DR IMPLANT SYSTEM
K002062 · EHD
Samsung Sds Co., Ltd.
Radiology · 126d
Cleared Nov 09, 2000
100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS
K002357 · IYO
Pie Medical
Radiology · 99d
Cleared Nov 09, 2000
REPLACE TPS COATED IMPLANTS
K002475 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared Nov 09, 2000
LUMBOPERITONEAL SHUNT SYSTEM
K002476 · JXG
Phoenix Biomedical Corp.
Neurology · 90d
Cleared Nov 09, 2000
PRECIMED TRAUMA SYSTEM
K002486 · HRS
Patrick Berdoz
Orthopedic · 87d
Cleared Nov 09, 2000
FETALGARD LITE
K002503 · HGM
Analogic Corp.
Obstetrics & Gynecology · 87d
Cleared Nov 09, 2000
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
K002687 · LDF
Zynergy Cardiovascular, Inc.
Cardiovascular · 72d
Cleared Nov 09, 2000
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
K002693 · EBL
Cbs Intl. B.V.
Dental · 72d
Cleared Nov 09, 2000
FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K002720 · LYY
Tillotson Healthcare Corp.
General Hospital · 70d
Cleared Nov 09, 2000
KENDRO HERACELL CO2 INCUBATOR
K002805 · MQG
Kendro Laboratory Products, L.P.
Obstetrics & Gynecology · 62d
Cleared Nov 09, 2000
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K003179 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Nov 08, 2000
ETEST LINEZOLID
K002139 · LTX
Ab Biodisk
Microbiology · 114d
Cleared Nov 08, 2000
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
K002459 · DPS
Agilent Technologies, Inc.
Cardiovascular · 90d
Cleared Nov 08, 2000
STELLAR
K002463 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 90d
Cleared Nov 08, 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 89d
Cleared Nov 08, 2000
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH...
K002499 · BZG
Brentwood Medical Technology Corp.
Anesthesiology · 86d
Cleared Nov 08, 2000
CERAM-PRIME
K002502 · KLE
S & C Polymer GmbH
Dental · 86d
Cleared Nov 08, 2000
FREEDOM AUTOMATIC FILM PROCESSOR
K002640 · IXW
J. Morita USA, Inc.
Radiology · 76d
Cleared Nov 08, 2000
PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING
K002707 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 70d
Cleared Nov 08, 2000
CARESIDE CHOLINESTERASE
K002792 · DIH
Careside, Inc.
Chemistry · 62d